| Drug Sponsor |
Sponsor |
Medical Review |
Clinical Pharmacology Review |
Statistical Review |
BPCA or PREA or Both |
| Abametapir - Xeglyze |
HATCHTECH PTY LTD |
Medical (PDF - 4 MB)
Addendum (PDF - 78 KB)
CDTL (PDF - 3 MB)
Resubmission (PDF - 77 KB)
DD (PDF - 2 MB)
|
Clinical pharmacology (PDF - 6 MB) |
Statistical (PDF - 207 KB) |
PREA |
| Abacavir and Lamivudine - Epzicom |
ViiV Healthcare Company |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 158 KB) |
Statistical (PDF - 693 KB) |
PREA |
| Abacavir, Dolutegravir, and Lamivudine - Triumeq |
ViiV Healthcare Company |
Medical (PDF - 443 KB) |
Clinical pharmacology (PDF - 128 KB) |
None |
PREA |
Abacavir, Dolutegravir, and Lamivudine - Triumeq
|
ViiV Healthcare Company c/o GlaxoSmithKline |
Medical (PDF - 389 KB)
CDTL (PDF - 798 KB)
|
Clinical pharmacology (PDF - 128 KB) |
None |
PREA |
| Abacavir, Dolutegravir, and Lamivudine - Triumeq PD |
ViiV Healthcare Company |
CDTL (PDF - 758 KB) |
Clinical pharmacology (PDF - 3 MB) |
None |
BOTH |
| Abacavir sulfate - Ziagen |
ViiV Healthcare Company |
Medical (PDF - 4.2 M B) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 5 MB) |
PREA |
| Abatacept - Orencia |
Bristol-Myers Squibb Company |
Medical (PDF - 259 KB)
Medical Addendum (PDF - 469 KB)
|
Clinical pharmacology (PDF - 2 MB)
Clinical pharmacology (PDF - 269 KB)
|
None |
BOTH |
| Abatacept - Orencia |
Bristol-Myers Squibb Company |
Medical (PDF - 4 MB) |
None |
None |
BPCA |
| AbobotulinumtoxinA - Dysport |
Ipsen Bipharm Limited |
CDTL Review (PDF - 2 MB)
Medical (PDF - 3 MB)
|
None |
Statistical (PDF - 2 MB) |
PREA |
| AbobotulinumtoxinA - Dysport |
Ipsen Bipharm Limited |
Medical (PDF - 1 MB) |
None |
Statistical (PDF - 857 KB) |
PREA |
Abrocitinib - Cibinqo
|
Pfizer Inc. |
Medical (PDF - 10 MB) |
None |
None |
PREA |
| Abrocitinib - Cibinqo |
Pfizer Inc. |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Acetaminophen - Ofirmev |
MallInc.krodt, Inc. |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 5 MB) |
Statistical (PDF - 378 KB) |
BOTH |
| Acetylcysteine - Legubeti |
Galephar Pharmaceutical Research Inc. |
Unireview (PDF - 6 MB)
Unireview CR (PDF - 10 MB)
|
None |
None |
PREA |
| Acyclovir 5%, hydrocortisone 1% - Xerese |
Valeant International Bermuda |
Medical (PDF - 885 KB) |
None |
None |
PREA |
Adalimumab-adaz - Hyrimoz
|
Sandoz Inc. |
Medical (PDF - 2 MB)
CDTL Review (PDF - 300 MB)
|
None |
None |
PREA |
|
Adalimumab-adaz - Hyrimoz
|
Sandoz Inc. |
CDTL Review (PDF - 342 KB)
|
None |
None |
PREA |
| Adalimumab-adaz - Hyrimoz |
Sandoz Inc. |
CDTL Review (PDF - 34 KB) |
None |
None |
PREA |
| Adalimumab-adbm - Cyltezo |
Boehringer Ingelheim |
Medical (PDF - 826 KB) |
None |
None |
PREA |
| Adalimumab-afzb - Abrilada |
Pfizer Inc. |
CDTL (PDF - 34 KB) |
None |
None |
PREA |
| Adalimumab-afzb - Abrilada |
Pfizer Inc. |
Medical (PDF - 1 MB) |
None |
None |
PREA |
| Adalimumab-afzb - Abrilada |
Pfizer Inc. |
CDTL (PDF - 34 KB) |
None |
None |
PREA |
| Adalimumab-aqvh - Yusimry |
Coherus BioSciences, Inc |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Adalimumab-aqvh - Yusimry |
Coherus BioSciences, Inc |
CDTL Review (PDF - 342 KB) |
Clinical pharmacology (PDF - 22 KB) |
None |
PREA |
| Adalimumab-atto - Amjevita |
Amgen Inc. |
CDTL Review (PDF - 4.3 MB)
Medical (PDF - 199K KB)
Medical (PDF - 336KB)
DD Summary Review (PDF - 3 MB)
|
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 416 KB)
Statistical (PDF - 363 KB)
Statistical (PDF - 717 KB)
|
PREA |
| Adalimumab-aaty - Yuflyma |
Celltrion, Inc. |
CDTL - DD (PDF - 356 KB) |
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Adalimumab-atto - Amjevita |
Amgen, Inc |
CDTL (PDF - 580 KB) |
None |
None |
PREA |
| Adalimumab-atto - Amjevita |
Amgen, Inc |
Medical (PDF - 532 KB) |
None |
None |
PREA |
Adalimumab-atto - Amjevita
|
Amgen, Inc |
Medical (PDF - 532 KB) |
None |
None |
PREA |
| Adalimumab-atto - Amjevita |
Amgen Inc. |
Medical (PDF - 25 KB) |
None |
None |
PREA |
| Adalimumab-bwwd - Hadlima |
Samsung Bioepis Co., Ltd. |
Medical (PDF - 34 KB) |
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
| Adalimumab-bwwd - Hadlima |
Samsung Bioepis Co., Ltd. |
Medical (PDF - 34 KB) |
None |
None |
PREA |
| Adalimumab-fkjp - Hulio |
Mylan Pharmaceuticals Inc. |
Medical (PDF - 2 MB) |
None |
None |
PREA |
Adalimumab-fkjp - Hulio
|
Mylan Pharmaceuticals Inc. |
Medical (PDF - 580 KB) |
None |
None |
PREA |
| Adalimumab-fkjp - Hulio |
Mylan Pharmaceuticals Inc. |
CDTL (PDF - 24 KB) |
None |
None |
RPEA |
| Adalimumab - Humira |
AbbVie,Inc. |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Adalimumab-aacf - Idacio |
Fresenius Kabi USA, LLC |
Medical (PDF - 20 MB) |
None |
None |
PREA |
| Adalimumab-aacf - Idacio |
Fresenius Kabi USA, LLC |
Medical (PDF - 20 MB) |
None |
None |
PREA |
| Adapalene and benzoyl peroxide - Epiduo |
Galderma Laboratories, LP |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF -124 KB) |
Statistical (PDF - 577 KB) |
PREA |
| Adapalene and benzoyl peroxide - Epiduo Forte |
Galderma Research and Development LLC |
Medical (PDF - 6.2 MB) |
Clinical pharmacology (PDF - 4 MB) |
Statistical (PDF - 2 MB) |
PREA |
|
Afatini - Gilotrif
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
Medical (PDF - 5 MB) |
None |
None |
BPCA |
Aflibercept - Eylea
|
Regeneron Pharmaceuticals, Inc. |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 5 MB) |
BPCA |
| Anidulafungin - Eraxis |
Vicuron Holdings LLC, a subsidiary of Pfizer Inc. |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Albuterol and Budesonide - Airsupra |
Bond Avillion 2 Development LP |
Medical (PDF - 12 MB) |
None |
None |
PREA |
| Albuterol sulfate - ProAir RespiClick |
Teva Pharmaceutical Products R. & D., Inc. |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 4 MB) |
Statistical (PDF - 2 MB) |
PREA |
| Albuterol sulfate - ProAir RespiClick |
Teva Branded Pharmaceutical Products R&D, Inc. |
Medical (PDF - 859 KB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 1 MB) |
PREA |
| Alirocumab - Praluent |
Regeneron Pharmaceuticals, Inc |
Medical (PDF - 859 KB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 1 MB) |
PREA |
| Aliskiren - Tekturna |
Noden Pharma DAC |
CDTL (PDF - 310 KB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 442 KB) |
BOTH |
| Alogliptin - Nesina |
Takeda Pharmaceuticals U.S.A., Inc |
Medical (PDF - 6 MB) |
Clinical pharmacology (PDF - 937 KB) |
Statistical (PDF - 536 KB) |
PREA |
| Alogliptin and metformin - Kazano |
Takeda Pharmaceuticals U.S.A., Inc. |
Medical (PDF - 6 MB) |
Clinical pharmacology (PDF - 937 KB) |
Statistical (PDF - 536 KB) |
PREA |
|
Amlodipine benzoate - Katerzia
|
Silvergate Pharmaceuticals, Inc |
Medical (PDF - 46 KB) |
Clinical pharmacology (PDF - 337 KB) |
None |
PREA
|
| Amphetamine - Adzenys ER |
Neos Therapeutics, Inc. |
Medical (PDF - 1.9 MB) |
Clinical pharmacology (PDF - 4 KB) |
None |
PREA |
| Amphetamine Extended-Release Orally Disintegrating Tablets - Adzenys XR-ODT |
Neos Therapeutics, Inc. |
Medical (PDF - 470 KB) |
Clinical pharmacology (PDF -3 MB) |
None |
PREA |
| Amphetamine - Dyanavel XR |
Tris Pharma |
Medical (PDF - 1.8 MB) |
Clinical pharmacology (PDF - 5 MB) |
Statistical (PDF - 767 KB) |
PREA |
| Amphetamine - Dyanavel XR |
Tris Pharma |
Medical (PDF - 848 KB)
CDTL Review (PDF - 1 MB)
|
None |
None |
PREA |
|
Amphetamine sulfate - Evekeo
|
Arbor Pharmaceuticals, LLC |
Medical (PDF - 1 MB)
Medical (PDF - 155 KB)
|
Clinical pharmacology (PDF - 9 KB)
Clinical pharmacology memo (PDF - 9 KB)
|
Statistical (PDF - 532 KB) |
PREA |
| Apremilast - Otezla |
Amgen, Inc |
Medical (PDF - 7 MB) |
None |
None |
PREA |
| Aprepitant - Emend |
Merck Sharp & Dohme Corp. |
Medical (PDF - 6 MB)
Medical Addendum (PDF -1 MB)
Medical DD memo (PDF - 3 MB)
|
Clinical pharmacology (PDF - 5 MB)
Clinical pharmacology addendum (PDF - 424 KB)
|
Statistical (PDF - 1 MB) |
PREA |
| Aprepitant - Emend |
Merck Sharp & Dohme Corp. |
Medical (PDF - 553 KB) |
Clinical pharmacology (PDF - 5 MB)
Addendum (PDF -105 KB)
|
Statistical (PDF - 1 MB) |
PREA |
| Aripiprazole - Abilify |
Otsuka |
Medical (PDF - 2.4MB) |
None |
Statistical (PDF - 409 KB) |
PREA |
| Asenapine - Saphris |
Forest Laboratories, Inc. |
Medical (PDF - 5 MB)
Medical (PDF - 4 MB)
|
Clinical pharmacology (PDF - 4 MB) |
Statistical (PDF - 3 MB) |
BOTH |
| Asparaginase erwinia chrysanthemi (recombinant)- rywn - Rylaze |
Jazz Pharmaceuticals Ireland Limited |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Atazanavir and cobicistat - Evotaz |
Bristol-Myers Squibb Company |
CDTL (PDF - 402 KB) |
Clinical pharmacology (PDF -1 MB) |
None |
PREA |
| Atazanavir - Reyataz |
Bristol-Myers Squibb Company |
Medical (PDF - 14 MB) |
Clinical pharmacology (PDF -1 MB) |
Statistical (PDF - 2 MB) |
BOTH |
| Atazanavir - Reyataz |
Bristol-Myers Squibb Company |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 4 MB) |
BOTH |
|
Atezolizumab - TECENTRIQ
|
Genentech, Inc. |
Medical (PDF - 1 MB) |
None |
None |
BPCA |
|
Atezolizumab - Tecentriq
|
Genentech, Inc. |
Medical (PDF - 3 MB) |
None |
None |
BPCA |
| Atorvastatin calcium - Atorvaliq |
CMP Development LLC |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
|
Atropine-pralidoxime - DueDote
|
Meridian Medical Technologies, Inc. |
CDTL (PDF - 402 KB)
Medical (PDF - 886 KB)
|
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
| Atropine Sulfate - Isopto Atropine 1% |
Alcon Research, Ltd. |
Medical (PDF - 663KB) |
Clinical pharmacology (PDF - 480KB) |
Statistical (PDF - 230KB) |
PREA |
| Atropine Sulfate Ophthalmic Solution |
Akorn, Inc. |
Medical (PDF - 1.2 MB) |
Clinical pharmacology (PDF - 1MB) |
Statistical (PDF - 287KB) |
PREA |
| Azelastine hydrochloride - Astepro |
Meda Pharmaceuticals |
Clinical (PDF -1 .4MB) |
None |
Statistical (PDF -473 KB |
PREA |
| Azelastine hydrochloride - Astepro |
Meda Pharmaceuticals Inc. |
Medical (PDF - 2MB) |
None |
None |
BOTH |
| Azelastine hydrochloride and Fluticasone propionate - Dymista |
Meda Pharmaceuticals, Inc. |
Medical (PDF - 2.9MB) |
None |
Statistical (PDF -2.1MB) |
BOTH |
| Baclofen - Fleqsuvy |
Azurity Pharmaceuticals, Inc. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 367 KB) |
None |
PREA |
| Baclofen - Lyvispah |
Saol Therapeutics Research Limited |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 448 KB) |
None |
PREA |
|
Baloxavir marboxil - Xofluza
|
Shionogi, Incorporated
|
CDTL (PDF - 869 KB)
Medical (PDF - 414 KB)
|
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 2 MB) |
PREA |
| Baloxavir marboxil - Xofluza |
Genentech, Incorporated |
CDTL (PDF - 853 KB)
Medical (PDF - 6 MB KB)
|
Clinical pharmacology (PDF - 420 KB) |
None |
PREA |
| Baloxavir marboxil - Xofluza |
Genentech, Incorporated |
Medical (PDF - 11 MB) |
None |
None |
PREA |
| Barium sulfate - E-Z-HD |
Bracco Diagnostics Inc. |
Medical (PDF - 2.4MB) |
Clinical pharmacology (PDF -642KB) |
Statistical (PDF -988KB) |
PREA |
| Barium sulfate - READI-CAT 2 & READI-CAT 2 SMOOTHIE |
Bracco Diagnostics |
Medical (PDF - 2.4MB) |
Clinical pharmacology (PDF - 702 KB) |
Statistical (PDF -1 MB) |
PREA |
| Barium sulfate - Varibar Pudding |
Bracco Diagnostics, Inc. |
Medical (PDF - 1MB) |
None |
None |
PREA |
| Barium sulfate - Liquid E-Z-Paque |
Bracco Diagnostics, Inc. |
DD Summary Review (PDF - 233 KB) |
None |
None |
PREA |
| Beclomethasone dipropionate - Qnasl |
Teva Branded Pharmaceutical Products R&D, Inc. |
Medical (PDF - 4 MB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF -959 KB) |
PREA |
|
Belumosudil - Rezurock
|
Kadmon Pharmaceuticals, LLC |
Medical (PDF - 7MB) |
Non |
None |
PREA |
| Belimumab - Benlysta |
Human Genome Sciences |
Medical (PDF - 6 MB) |
None |
None |
PREA |
| Belimumab - Benlysta |
GlaxoSmithKline LLC |
Medical (PDF - 7 MB) |
None |
None |
PREA |
| Benralizumab - Fasenra |
AstraZeneca AB |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 7 MB) |
Statistical (PDF - 2 MB) |
PREA |
| Benralizumab - Fasenra |
AstraZeneca AB c/o AstraZeneca Pharmaceuticals LP |
Medical (PDF - 7 MB)
Unireview (PDF - 11 KB)
|
None |
None |
PREA |
| Berdazimer - Zelsuvmi |
LNHC, Inc. |
Medical (PDF - 12 MB) |
None |
None |
PREA |
| Bezlotoxumab - Zinplava |
Merck Sharp & Dohme Corp. |
Medical (PDF - 2 MB) |
None |
None |
BOTH |
| Bictegravir, emtricitabine, and tenofovir alafenamide - Biktarvy |
Gilead Sciences, Inc. |
CDTL (PDF - 157 KB)
CDTL 1 (PDF - 2 MB)
|
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Bictegravir, emtricitabine, and tenofovir alafenamide - Biktarvy |
Gilead Sciences, Inc. |
CDTL (PDF - 2 MB) |
Clinical pharmacology (PDF - 4 MB) |
None |
PREA |
| Bimatoprost ophthalmic solution, 0.03% - Latisse |
Allergan, Inc. |
DD Summary Review (PDF - 966KB)
CDTL Review (PDF - 3 MB)
Medical (PDF - 2 MB)
|
None |
Statistical (PDF -946KB)
Statistical Addendum (PDF - 127KB)
|
PREA |
|
Blinatumomab - Blincyto
|
Amgen, Inc. |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF -1 MB) |
Statistical (PDF -374 KB) |
BPCA |
| Blinatumomab - Blincyto |
Amgen, Inc. |
Medical (PDF - 9 MB) |
None
|
None |
BPCA |
| Bortezomib - Velcade |
Millennium Pharmaceuticals, Inc. |
Medical (PDF - 4 MB) |
Clinical pharmacology (PDF -1 MB) |
Statistical (PDF - 374 KB) |
BPCA |
| Bosutinib - BOSULIF |
PF Prism C.V |
Medical (PDF - 10 MB) |
None |
None |
BPCA |
| Budesonide - Entocort EC |
Elan Pharma International |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 3 MB) |
Clinical pharmacology (PDF - 3 MB) |
PREA |
| Brentuximab vedotin - Adcetris |
Seagen Inc. |
Medical (PDF - 1 MB) |
None |
None |
BPCA |
|
Brexanolone - Zulresso
|
Sage Therapeutics, Inc. |
Medical (PDF - 1 MB) |
None |
None |
PREA |
Brexpiprazole - Rexulti
|
Otsuka Pharmaceutical Company, Ltd. |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Brimonidine tartrate - Lumify |
Bausch + Lomb |
CDTL Review (PDF - 3 MB)
Medical (PDF - 556 KB)
|
Clinical pharmacology (PDF - 51 KB) |
Statistical (PDF - 219 KB) |
PREA |
| Brivaracetam - Briviact |
UCB, Inc. |
CDTL Review (PDF - 297 KB)
Medical (PDF - 1 MB)
|
Clinical pharmacology (PDF - 2 MB) |
None |
PREA
|
| Brivaracetam - Briviact |
UCB, Inc. |
Medical (PDF - 74 KB) |
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Budesonide/formoterol fumarate dehydrate - Symbicort |
AstraZeneca Pharmaceuticals, LP |
Medical (PDF - 3.4 MB) |
Clinical pharmacology (PDF - 1.2 MB) |
Statistical (PDF - 2.5 MB) |
BOTH |
| Bupivacaine - Exparel |
Pacira Pharmaceuticals, Inc. |
Medical (PDF - 6 MB) |
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Buprenorphine - Butrans |
Purdue Pharma L.P. |
Medical (PDF - 4.1 MB) |
Clinical pharmacology (PDF - 1.5 MB) |
None |
PREA |
| Cabazitaxel - Jevtana |
Sanofi-Aventis U.S., L.L.C. |
Medical (PDF - 1.5 MB) |
Clinical pharmacology (PDF - 1.2 MB) |
None |
BPCA |
|
Cabotegravir - Apretude
|
ViiV Healthcare Company |
Medical (PDF - 8 MB) |
None |
None |
PREA |
Cabotegravir-rilpivirine - Cabenuva
|
ViiV Healthcare Company |
Medical (PDF - 35 KB) |
Clinical pharmacology (PDF - 1 MB)
Clinical pharmacology Addendum (PDF - 229 KB)
|
None |
PREA |
| Cabotegravir - Vocabria |
ViiV Healthcare Company |
CDTL (PDF - 1 MB)
Medical (PDF - 525 KB)
|
Clinical pharmacology (PDF - 2 MB)
Addendum (PDF - 115 KB)
|
None |
PREA |
| Calcipotriene - SORILUX Foam |
Mayne Pharma LLC |
Medical (PDF - 525 KB) |
None |
None |
PREA |
| Calcipotriene - SORILUX |
Mayne Pharma LLC |
Medical (PDF - 525 KB) |
Clinical pharmacology (PDF - 1.2 MB) |
None |
PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex |
LEO Pharma A/S |
Medical (PDF -5.6MB) |
Clinical pharmacology (PDF -2.4MB) |
Statistical (PDF -564 KB) |
PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex |
LEO Pharma A/S c/o LEO Pharma, Inc. |
Medical (PDF - 3.7MB) |
Clinical pharmacology (PDF -2.7MB) |
None |
PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex |
LEO Pharma A/S |
Medical (PDF - 775 KB) |
Clinical pharmacology (PDF - 528 KB) |
None |
PREA |
| Calcipotriene and betamethasone - Enstilar |
LEO Pharma A/S |
Medical (PDF - 775 KB) |
N |
None |
BOTH |
| Calcium Gluconate injection - Calcium Gluconate Injection |
Fresenius Kabi USA, LLC |
Medical (PDF - 4 MB)
Medical CTDL (PDF - 1.5 MB)
|
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
Calcitriol - Vectical
|
Galderma Laboratories, L.P. |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
| Cantharidin - Ycanth |
Verrica Pharmaceuticals Inc. |
Medical (PDF - 3 MB) |
None |
None |
PREA |
| Capecitabine - Xeloda |
Hoffmann-La Roche, Inc. |
Medical (PDF - 4MB) |
Clinical pharmacology (PDF - 1MB) |
Statistical (PDF -610 KB) |
BPCA |
| Carbinoxamine maleate - Karbinal ER |
Tris Pharma, Inc. |
Medical (PDF - 1.4MB) |
Clinical pharmacology (PDF - 500 KB) |
None |
PREA |
| Cefazolin sodium and dextrose solution - Cefazolin for Injection USP and Dextrose Injection USP in the Duplex® Container |
B. Braun Medical Inc. |
Medical (PDF - 1 MB) |
None |
None |
PREA |
| Ceftaroline fosamil - Teflaro |
Cerexa, Inc., A Subsidiary of Forest Laboratories, LLC |
Medical (PDF - 11 MB)
Medical CTDL (PDF - 2 MB)
|
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF -1 MB) |
PREA |
| Ceftaroline fosamil - Teflaro |
Allergan Sales, LLC |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Ceftazidime and Avibactam - Avycaz |
Allergan Sales, LLC |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Ceftazidime and avibactam - Avycaz |
Allergan Sales, LLC |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Ceftazidime and avibactam - Avyca |
AbbVie, Inc. |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Ceftobiprole medocaril sodium for injection - Zevtera |
Basilea Pharmaceutica International, Ltd., Allschwil |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Ceftolozane and tazobactam - Zerbaxa |
Cubist Pharmaceuticals, LLC |
Medical (PDF - 8 MB) |
None |
None |
PREA |
| Certolizumab pegol - Cimzia |
UCB, Inc |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Cetirizine ophthalmic solution - Zerviate |
Nicox Ophthalmics, Inc. |
Medical Resubmission (PDF - 231 KB)
Medical (PDF - 5 MB)
|
Clinical pharmacology (PDF - 279 KB) |
Statistical (PDF - 580 KB) |
BOTH |
| Cetirizine hydrochloride - Quzyttir |
JDP Therapeutics Inc |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Ciclesonide - Zetonna |
Takeda GmbH |
Medical (PDF - 5 MB)
|
Clinical pharmacology (PDF -1 MB) |
Statistical (PDF -674 KB) |
PREA |
| Cinacalcet hydrochloride - Sensipar |
|
CDTL (PDF - 2.2 MB)
Medical (PDF - 4.1 MB)
|
Clinical pharmacology (PDF - 5.6 MB) |
Statistical (PDF - 957 KB) |
BOTH |
| Ciprofloxacin 0.3% and Fluocinolone acetonide 0.025% - Otovel Otic Solution |
Laboratorios SALVAT, S.A. |
Medical (PDF - 4MB) |
Clinical pharmacology (PDF -632 KB) |
Statistical (PDF -2MB) |
PREA |
| Ciprofloxacin otic suspension - Otiprio |
Otonomy, Inc. |
Medical (PDF - 233 KB) |
Clinical pharmacology (PDF - 79 KB) |
Statistical (PDF - 213 MB |
PREA |
| 6% Ciprofloxacin Otic Suspension - Otiprio |
Otonomy, Inc. |
Medical (PDF - 2.3MB) |
Clinical pharmacology (PDF - 97 KB) |
Statistical (PDF -896 KB)
Addendum (PDF -157 KB
|
PREA |
| Ciprofloxacin ophthalmic solution - Ciloxan |
Novartis Pharmaceuticals Corporation |
Medical (PDF - 110 KB)
Medical (PDF - 173 KB)
|
None |
None |
BPCA |
|
Clascoterone - Winlevi
|
Cassiopea SpA |
Medical (PDF - 3 MB) |
None |
None |
PREA |
|
Clindamycin phosphate, adapalene, and benzoyl peroxid - Cabtreo
|
Bausch Health US, LLC |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Clindamycin phosphate - Xaciato |
Daré Bioscience Inc. |
Medical (PDF - 3 MB) |
None |
None |
PREA |
| Clonidine - Kapvay |
Concordia Pharms Inc. |
Medical (PDF - 3 MB) |
None |
Statistical (PDF -2MB) |
PREA |
| Cobicistat - Tybost |
Gilead Sciences, Inc. |
CDTL (PDF - 1 MB) |
Clinical pharmacology (PDF - 1 MB) |
None |
BOTH |
Cobimetinib - Cotellic
|
Genentech, Inc. |
Medical (PDF - 27 KB) |
Clinical pharmacology (PDF - 543 KB) |
None |
BPCA |
| Colesevelam HCl - Welchol |
Daiichi Sankyo Inc. |
CDTL (PDF - 2 MB)
Medical (PDF - 12MB)
|
Clinical pharmacology (PDF - 7 MB) |
None |
PREA |
| Colesevelam HCl - Welchol |
Daiichi Sankyo Inc. |
Medical (PDF - 3 MB) |
None |
Statistical (PDF - 308 KB) |
PREA |
| Crisaborole Ointment, 2% - Eucrisa |
Anacor Pharmaceuticals Inc. |
CDTL Review (PDF - 2MB)
Medical (PDF - 12MB)
|
Clinical pharmacology (PDF - 7MB) |
Statistical (PDF - 1MB) |
PREA |
| Crisaborole - Eucrisa |
Anacor Pharmaceuticals, LLC. |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Crisaborole - Eucrisa |
Pfizer |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 1 MB) |
None |
BPCA |
| Cysteamine bitartrate - Procysbi |
Raptor Pharmaceuticals, Inc. |
Medical (PDF -12MB) |
Clinical pharmacology (PDF - 2 MB)
Clinical pharmacology addendum (PDF - 420 KB)
|
None |
BPCA |
| Cysteamine bitartrate - Procysbi |
Horizon Pharma USA, Inc.
|
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 1 MB) |
BPCA |
| Cysteamine hydrochloriden - CYSTADROPS |
Recordati Rare Diseases Inc. |
Medical (PDF - 294 KB) |
None |
None |
PREA |
Dabigatran etexilate - Pradaxa
|
Boehringer Ingelheim Pharmaceuticals, Inc. |
Medical (PDF - 2 MB)
Medical (PDF - 700 KB)
|
Clinical pharmacology (PDF - 5 MB) |
None |
BOTH |
| Dabrafenib - Tafinlar |
Novartis Pharmaceuticals Corporation |
Medical (PDF - 18 MB) |
None |
None |
PREA |
| Dabrafenib - Tafinlar |
Novartis Pharmaceuticals Corporation |
Medical (PDF - 10 MB)
CDTL (PDF - 1 MB)
|
Clinical pharmacology (PDF - 579 KB) |
None |
BPCA |
|
Dalbavancin hydrochloride - Dalvance
|
Allergan Sales, LLC |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Dalteparin sodium - Fragmin |
Pharmacia & Upjohn, a subsidiary of Pfizer Inc. |
Medical (PDF - 3.5 MB) |
None |
None |
PREA |
| Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide - Symtuza |
Jannsen |
Medical (PDF - 3.5 MB) |
Clinical pharmacology (PDF - 1.2MB) |
None |
PREA |
| Dapsone - Aczone |
Allergan, Inc. |
Medical (PDF - 3.5 MB) |
Clinical pharmacology (PDF - 2.6 MB) |
Statistical (PDF -1.3 MB) |
PREA |
| Dapsone - Aczone |
Almirall, LLC |
Medical (PDF - 3.5 MB) |
Clinical pharmacology (PDF - 2.6 MB) |
None |
PREA |
| Daptomycin - Cubicin |
Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp. |
Medical (PDF - 505 KB) |
Clinical pharmacology (PDF - 1.8 MB)
|
Statistical (PDF -1.9 KB)
Statistical Addendum (PDF - 96 KB)
|
PREA |
| Daptomycin - Cubicin |
Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp. |
Medical (PDF - 389 KB) |
Clinical pharmacology (PDF - 991 KB)
Clinical pharmacology Addendum (PDF - 80 KB)
|
Statistical (PDF - 374 KB)
|
PREA |
Daptomycin - Dapzura RT
|
Baxter Healthcare Corporation |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Darbepoetin alfa - Aranesp |
Amgen Inc. |
Medical (PDF - 2 MB) |
None |
Statistical (PDF -280KB) |
BPCA |
| Darunavir and Cobicistat - Prezcobix |
Janssen Products, LP |
Medical (PDF - 147 KB) |
Clinical pharmacology (PDF - 20 KB) |
None |
PREA |
| Darunavir - Prezista |
Janssen Products, L.P. |
Medical (PDF -1MB) |
Clinical pharmacology (PDF -1MB) |
None |
PREA |
| Darunavir - Prezista |
Janssen Products, L.P. |
None |
Clinical pharmacology (PDF -352KB) |
None |
PREA |
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide - Symtuza |
Janssen Products, L.P. |
Multi-disciplinary review (PDF - 8 MB) |
None |
None |
PREA |
|
Dasatinib - Sprycel
|
Bristol-Myers Squibb Company
|
CDTL Review (PDF - 1 MB)
Medical (PDF- 8 MB)
|
Clinical pharmacology (PDF - 531 KB)
|
Statistical (PDF - 19 KB) |
BPCA |
| Dasiglucagon - Zegalogue |
Zealand Pharma A/S |
Medical (PDF - 5MB) |
Clinical pharmacology (PDF - 33KB)
Clinical pharmacology Addendum (PDF - 38KB)
|
Statistical (PDF - 2MB) |
PREA |
| Daunorubicin and cytarabine (liposome injection) - Vyxeos |
Jazz Pharmaceuticals |
Multidisciplinary (PDF - 5 MB) |
None |
None |
BPCA |
| Decitabine - Dacogen |
Eisai Inc. |
Medical (PDF -2 MB) |
Clinical pharmacology (PDF -1MB) |
None |
BPCA |
| Deferasirox - Exjade |
Novartis Pharmaceuticals Corporation |
Medical (PDF - 9 MB) |
Clinical pharmacology (PDF - 1.5MB) |
Statistical (PDF - 2MB) |
BPCA |
| Deferasirox - Exjade |
Novartis Pharmaceuticals Corporation |
CDTL Review (PDF - 795 KB)
Medical (PDF - 843 KB)
|
None |
None |
BPCA |
| Deferasirox - Jadenu |
Novartis Pharmaceuticals Corporation |
CDTL Review (PDF - 2MB)
Medical (PDF - 1 MB)
|
Clinical pharmacology (PDF - 1MB) |
None |
BPCA |
| Desoximetasone - Topicort |
Taro Pharmaceuticals U.S.A., Inc. |
Medical (PDF - 221 KB) |
Clinical pharmacology (PDF - 302 KB) |
None |
PREA |
| Desvenlafaxine - Pristiq |
Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. |
Medical (PDF - 103 KB)
Medical (PDF - 622 KB)
|
Clinical pharmacology (PDF - 1.5 MB) |
Statistical (PDF - 1.5 MB) |
PREA |
|
Deutetrabenazine - Austedo
|
Teva Branded Pharmaceutical Products R&D, Inc. |
Medical (PDF - 622 KB) |
None |
None |
BPCA |
| Dexlansoprazole - Dexilant |
Takeda Pharmaceuticals USA Inc. |
CDTL Review (PDF-661 KB)
Medical (PDF-5 MB)
|
Clinical pharmacology (PDF-1MB) |
Statistical (PDF-50KB) |
PREA |
| Dexmedtomidine hydrochloride - Precedex |
Hospira |
Medical (PDF -5MB) |
Clinical pharmacology (PDF -3.8MB) |
Statistical (PDF -1MB) |
BPCA |
| Dexmedetomidine - Precedex |
Hospira, Inc. |
CDTL Review (PDF - 3 MB) |
Clinical pharmacology (PDF -3.8MB) |
Statistical (PDF - 1MB) |
PREA |
| Dextroamphetamine - Xelstrym |
Noven Pharmaceuticals, Inc. |
Medical (PDF - 1 MB) |
None |
None |
PREA |
|
Diclofenac epolamine topical system 1.3% - Flector
|
IBSA Institut Biochimique SA
|
Medical (PDF - 1 MB)
|
None |
None |
PREA |
Diclofenac potassium - Zipsor
|
Assertio Therapeutics, Inc. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 453 KB) |
None |
PREA |
| Difluprednate ophthalmic emulsion - Durezol |
Alcon Pharmaceuticals Ltd. c/o Alcon Research Ltd |
Medical (PDF -748 KB) |
Clinical pharmacology (PDF - 40KB) |
Statistical (PDF - 479KB) |
BPCA |
| Dolutegravir and lamivudine - Dovato |
ViiV Healthcare Company |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Dolutegravir - Tivicay |
ViiV Healthcare |
Medical (PDF - 8MB) |
Clinical pharmacology (PDF -11 MB) |
Statistical (PDF -4MB) |
PREA |
| Dolutegravir - Tivicay |
ViiV Healthcare |
Medical (PDF - 2 MB)
CDTL Review (PDF - 932 KB)
|
Clinical pharmacology (PDF -2.2MB) |
None |
PREA |
| Dolutegravir - Tivicay PD |
ViiV Healthcare |
Medical (PDF - 241KB) |
Clinical pharmacology (PDF -89KB) |
None |
PREA |
| Doravirine/lamivudine/tenofovir disoproxil fumarate - Delstrigo |
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
CDTL Review (PDF - 962 KB) |
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Doxycycline hyclate delayed-release - Doryx |
Mayne Pharma International, Pty, Ltd. c/o Warner Chilcott US, LLC |
Medical (PDF - 241 KB) |
Clinical pharmacology (PDF - 89 KB) |
Statistical (PDF - 131 KB) |
PREA |
| Doxycycline hyclate - LymePak |
Chartwell Pharma NDA B2 Holdings, LLC |
Medical (PDF - 1 MB) |
None |
None |
PREA |
Drospirenone and estetrol tablets - Nextstellis
|
Mayne Pharma LLC |
Medical (PDF - 3 MB) |
None |
None |
PREA |
| Drospirenone - Slynd |
Exeltis USA, Inc |
Medical (PDF - 1 MB) |
None |
None |
PREA |
| Dulaglutide - Trulicity |
Eli Lilly and Company |
CDTL (PDF - 1 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 2 MB) |
BOTH |
| Duloxetine - Cymbalta |
Eli Lilly and Company, Inc. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF -197KB) |
Statistical (PDF - 3 MB) |
PREA |
| Duloxetine - Cymbalta |
Eli Lily and Company, Inc. |
Medical (PDF - 2 MB) |
None |
None |
PREA |
Duloxetine delayed-release capsules - Drizalma Sprinkle
|
Sun Pharma Global FZE |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Duloxetine hydrochloride - Cymbalta |
Eli Lilly and Company |
Medical (PDF - 8 MB) |
Clinical pharmacology (PDF - 959 KB) |
Statistical (PDF -665 KB) |
BPCA |
| Dupilumab - Dupixent |
Regeneron Pharmaceuticals, Inc. |
Medical (PDF - 8 MB) |
None |
None |
PREA |
| Dupilumab - Dupixent |
Regeneron Pharmaceuticals, Inc. |
Medical (PDF - 8 MB) |
None |
None |
PREA |
| Dupilumab - Dupixent |
Regeneron Pharmaceuticals, Inc. |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Dupilumab - Dupixent |
Regeneron Pharmaceuticals, Inc. |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Dupilumab - Dupixent |
Regeneron Pharmaceuticals, Inc. |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Econazole nitrate - Ecoza |
AmDerma Pharmaceuticals, LLC |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 422KB) |
PREA |
| Edoxaban - Savaysa |
Daiichi Sankyo, Inc. |
CDTL (PDF - 4 MB)
Medical (PDF - 4 MB)
|
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
| Efavirenz, lamivudine, tenofovir - Symfi Lo |
Mylan Pharmaceuticals, Inc. |
Medical (PDF - 129 KB) |
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
| Efavirenz, lamivudine, tenofovir Disoproxil Fumarate - Symfi |
Mylan Pharmaceuticals, Inc. |
Medical (541 - KB) |
None |
None |
PREA |
| Efavirenz, Lamivudine and Tenofovir disoproxil fumarate |
Aurobindo Pharma Limited, India |
DD Review (PDF - 65 KB) |
Clinical pharmacology (PDF - 788 KB) |
None |
PREA |
|
Efavirenz, lamivudine, tenofovir disoproxil fumarate
|
Macleods Pharmaceuticals Limited, India |
Medical (PDF - 1.9MB) |
Clinical pharmacology (PDF - 788 KB) |
None |
PREA |
| Efavirenz - Sustiva |
Bristol-Myers Squibb Company |
Medical (PDF -1.9MB) |
Clinical pharmacology (PDF -9.3MB) |
None |
BOTH |
| Efinaconazole - Jublia |
Bausch Health Americas, Inc.
|
Medical (PDF - 538 KB) |
None |
None |
PREA |
|
Elbasvir and grazoprevir - Zepatier
|
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
| Eltrombopag - Alvaiz |
Teva Pharmaceuticals Inc. |
CDTL (PDF - 2 MB)
Medical (PDF - 583 MB)
|
Clinical pharmacology (PDF - 975 MB) |
None |
PREA |
| Eltrombopag - Promacta |
Novartis Pharmaceuticals Corporation |
Medical (PDF - 4 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF -1MB) |
BPCA |
| Eltrombopag - Promacta |
Novartis Pharmaceuticals Corporation |
Medical (PDF - 58 KB) |
None |
None |
BPCA |
| Eltrombopag - Promacta |
Novartis Pharmaceuticals Corporation |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 97 KB) |
BPCA |
| Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya |
Gilead Sciences, Inc. |
Medical (PDF -13.4MB) |
Clinical pharmacology (PDF -24.2MB) |
Statistical (PDF -2.2MB) |
PREA |
| Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya |
Gilead Sciences, Inc. |
Medical (PDF - 642 KB) |
Clinical pharmacology (PDF - 242 KB) |
None |
BOTH |
|
Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya
|
Gilead Sciences, Inc. |
CDTL (PDF - 3 MB) |
Clinical pharmacology (PDF - 9 MB) |
None |
BOTH |
| Elvitegravir, Cobicistat, Emtricitabine/Tenofovir Disoproxil Fumarate - Stribild |
Gilead Sciences, Inc. |
CTDL Review (PDF -359KB) |
Clinical pharmacology (PDF - 462KB) |
None |
PREA |
| Empagliflozin - Jardiance |
Boehringer Ingelheim Pharmaceuticals, Inc. |
Medical - CDTL (PDF - 7 MB) |
Clinical pharmacology (PDF - 4 MB) |
Statistical (PDF - 2 MB) |
BPCA |
| Empagliflozin and Metformin - Synjardy |
Boehringer Ingelheim Pharmaceuticals, Inc. |
CDTL (PDF - 7 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 3 MB) |
BPCA |
| Empagliflozin and Metformin - Synjardy XR |
Boehringer Ingelheim Pharmaceuticals, Inc. |
CDTL (PDF - 7 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 3 MB) |
BPCA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Odefsey |
Gilead Sciences, Inc. |
Medical (PDF - 310KB)
CTDL Review (PDF - 578KB)
|
Clinical pharmacology (PDF - 5MB)
Clinical pharmacology addendum (PDF - 297 KB)
|
None |
PREA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Descovy |
Gilead Sciences, Inc. |
Medical (PDF - 1 MB)
Addendum (PDF - 572KB)
|
Clinical pharmacology (PDF -8 MB) |
Statistical (PDF -2 MB) |
PREA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Descovy |
Gilead Sciences, Inc. |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 8 MB) |
Statistical (PDF - 2 MB) |
PREA |
| Emtricitabine and tenofovir alafenamide - Descovy |
Gilead Sciences, Inc. |
Medical (PDF - 642 KB) |
Clinical pharmacology (PDF -145 KB) |
None |
PREA |
| Emtricitabine and tenofovir alafenamide - Descovy |
Gilead Sciences, Inc. |
CDTL Review (PDF - 2 MB) |
None |
None |
PREA |
| Emtricitabine, Rilpivirine, and Tenofovir isoproxil fumarate - Complera |
Gilead Sciences, Inc. |
Medical (PDF - 1MB) |
Clinical pharmacology (PDF -145 KB) |
None |
PREA |
| Emtricitabine and Tenofovir disoproxil fumarate - Truvada |
Gilead Sciences, Inc. |
Medical (PDF - 501KB) |
Clinical pharmacology (PDF -189KB) |
None |
PREA |
| Entecavir - Baraclude |
Bristol-Myers Squibb Company |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 3MB) |
Statistical (PDF -660 KB) |
BOTH |
| Entrectinib - Rozlytrek |
Genentech |
Medical (PDF - 23 MB) |
None |
None |
BPCA |
| Entrectinib - Rozlytrek |
Genentech, Inc. |
Medical (PDF - 14 MB) |
None |
None |
BPCA |
| Erlotinib - Tarceva |
OSI Pharmaceuticals, LLC |
Medical (PDF - 6 MB) |
Clinical pharmacology (PDF -2 MB) |
None |
BPCA |
| Eribulin mesylate - Halaven |
Eisai Inc. |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 2 MB) |
None |
BPCA |
| Epinephrine - Auvi-Q |
Kaleo, Inc. |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Epinephrine - Primatene Mist |
Armstrong Pharmaceuticals, Inc. |
CDTL Review (PDF - 2 MB)
Medical (PDF - 4 MB)
|
None |
Statistical (PDF - 660 KB) |
PREA |
| Escitalopram oxalate - Lexapro |
Forest Laboratories, Inc. |
Medical (PDF - 218 KB) |
None |
None |
PREA |
| Escitalopram - Lexapro |
AbbVie Inc. |
Medical (PDF - 6 MB) |
None |
None |
PREA |
| Eslicarbazepine acetate - Aptiom |
Sunovion Pharmaceutical Inc. |
CDTL Review (PDF - 593 KB)
Medical (PDF - 5 MB)
|
Clinical pharmacology (PDF - 2.9 KB) |
None |
PREA |
| Eszopiclone - Lunesta |
Sunovion Pharmaceuticals, Inc. |
Medical (PDF - 1MB) |
Clinical pharmacology (PDF -883KB) |
None |
BOTH |
| Etafilcon - Theravision with Ketotifen |
Johnson & Johnson Vision Care, Inc. |
DD Review (PDF - 2 MB)
Medical (PDF - 460 KB)
|
None |
Statistical (PDF - 3 MB) |
PREA |
| Etanercept - Enbrel |
Immunex Corporation, a wholly-owned subsidiary of Amgen Inc. |
Medical (PDF - 4.8 MB)
DD Review (PDF - 568 KB)
CDTL Review PDF - 504 KB)
|
Clinical pharmacology (PDF - 702 KB) |
Statistical (PDF - 444 KB) |
PREA |
| Etanercept - Enbrel |
Amgen Inc. |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Etanercept-szzs - Erelzi |
Sandoz Inc. |
Medical (PDF - 1.7 MB) |
Clinical pharmacology (PDF - 4.7 MB) |
Statistical (PDF - 432 KB) |
PREA |
Etanercept-szzs - Erelzi
|
Sandoz Inc. |
CDTL Review PDF - 504 KB)
|
None |
None |
PREA |
Etanercept-szzs - Erelzi
|
Sandoz Inc. |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Etravirine - Intelence |
Janssen Products, LP |
Medical (PDF -1.4MB) |
Clinical pharmacology (PDF -1.7MB) |
None |
BOTH |
| Etravirine - Intelence |
Janssen Products, LP |
Medical (PDF -1 MB) |
Clinical pharmacology (PDF - 896 KB) |
None |
BOTH |
| Everolimus tablets for oral suspension - Afinitor Disperz |
Novartis Pharmaceuticals Corporation |
Medical (PDF -10MB) |
Clinical pharmacology (PDF -2MB) |
None |
BPCA |
| Evolocumab - Repatha |
Amgen, Inc. |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 1 MB) |
PREA |
| Exenatide - Bydureon |
AstraZeneca Pharmaceuticals AB C/O AstraZeneca Pharmaceuticals LP |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 1 MB) |
BOTH |
| Exenatide - Byetta |
AstraZeneca AB |
Medical (PDF - 802 KB) |
Clinical pharmacology (PDF - 14 KB) |
Statistical (PDF - 122 KB) |
BOTH |
Fenfluramine HCl - Fintepla
|
Zogenix, Inc. |
Medical (PDF - 588 KB) |
Clinical pharmacology (PDF - 2 MB) |
None |
BPCA |
| Ferric oxyhydroxide - Velphoro |
Vifor Fresenius Medical Care Renal Pharma France |
Medical (PDF - 1 MB) |
None |
None |
BPCA |
| Ferric carboxymaltose -Injectafer |
American Regent, Inc. |
Medical (PDF - 613 KB) |
Clinical pharmacology (PDF - 7 MB) |
None |
PREA |
| Fesoterodine fumarate - Toviaz |
Pfizer, Inc.
|
Medical (PDF - 4 MB) |
Clinical pharmacology (PDF - 6 MB) |
Statistical (PDF - 300 KB) |
PREA |
|
Fidaxomicin - Dificid
|
Cubist Pharmaceuticals LLC |
Medical (PDF -3.8MB) |
None |
None |
BPCA |
| Filgrastim-sndz - Zarxio |
Sandoz, Inc. |
Medical (PDF -3.8MB)
DD Review (PDF -86KB)
TL Review (PDF -422KB)
|
Clinical pharmacology (PDF -2.75MB)
Addendum (PDF - 1.1MB)
|
Statistical (PDF -6742KB) |
PREA |
| Filgrastim-aafi - Nivestym |
Hospira, Inc. |
CDTL Review (PDF - 746 KB)
Medical (PDF - 245 KB)
|
Clinical pharmacology (PDF - 661 KB) |
Statistical (PDF - 377 KB) |
PREA |
| Finafloxacin otic suspension - Xtoro |
Alcon Research, Ltd. |
Medical (PDF -6.8MB) |
Clinical pharmacology (PDF -2MB) |
Statistical (PDF -3.2MB) |
BOTH |
| Fingolimod - Gilenya |
Novartis Pharmaceuticals Corporation |
CDTL Review (PDF - 2 MB)
Medical (PDF - 3.8 MB)
|
Clinical pharmacology (PDF -2MB) |
Statistical (PDF -3.2MB) |
BOTH |
| Fingolimod - Tascenso ODT |
Handa Neuroscience, LLC
|
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
| Fluticasone furoate inhalation powder - Arnuity Ellipta |
GlaxoSmithKline |
Medical (PDF -8.6MB) |
Clinical pharmacology (PDF -5.7MB) |
Statistical (PDF -1.9) |
PREA |
| Fluticasone furoate - Arnuity Ellipta |
GlaxoSmithKline |
Medical (PDF - 956 KB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 507 KB) |
PREA |
| Fluticasone furoate - Arnuity Ellipta |
GlaxoSmithKline Intellectual Property Development Ltd. England |
Medical (PDF - 956 KB) |
None |
None |
PREA |
| Fluticasone furoate - Flonase Sensimist Allergy Relief |
Haleon US Holdings |
Medical (PDF - 489 KB) |
None |
Statistical (PDF - 133 KB) |
PREA |
| Fluticasone Furoate/Umeclidinium/Vilanterol - Trelegy Ellipta |
GlaxoSmithKline Intellectual Property Development Ltd. England |
Medical (PDF - 3MB) |
None |
None |
PREA |
Fluticasone furoate/vilanterol - Breo Ellipta
|
GlaxoSmithKline |
Medical (PDF - 16 MB) |
Clinical pharmacology (PDF - 5 MB) |
Statistical (PDF - 4 MB) |
PREA |
| Fluticasone furoate and vilanterol - Breo Ellipta |
GlaxoSmithKline Intellectual Property Development Ltd. England C/o GlaxoSmithKline Research & Development |
Medical (PDF - 6 MB) |
None |
None |
BPCA |
| Fluticasone propionate Lotion - Cutivate |
Fougera Pharmaceuticals Inc. |
Medical (PDF -1.2MB) |
Clinical pharmacology (PDF -1.4MB) |
None |
PREA |
| Fluticasone propionate/salmeterol xinafoate - Advair HFA |
GlaxoSmithKline |
Medical (PDF -1 MB) |
Clinical pharmacology (PDF -267KB) |
Statistical (PDF -52 KB) |
PREA |
| Fluticasone propionate - ArmonAir RespiClick |
Teva Pharmaceutical Industries Ltd. |
Medical (PDF -10 MB) |
Clinical pharmacology (PDF - 4.3MB) |
Statistical (PDF -1.2 KB) |
PREA |
|
Fluticasone propionate - ArmonAir RespiClick
|
Teva Pharmaceutical Industries Ltd. c/o: Teva Branded Pharmaceutical Products R&D Inc. |
Medical (PDF - 6 MB) |
None |
None |
BOTH |
| Fluticasone propionate/salmeterol - AirDuo |
Teva Pharmaceutical Industries Ltd. |
Medical (PDF -10 MB) |
Clinical pharmacology (PDF - 4.3 MB) |
Statistical (PDF -1.2 KB) |
PREA |
|
Formoterol fumarate and mometasone furoate - Dulera
|
Merck Sharp & Dohme Corp. |
Medical (PDF - 10 MB) |
None |
None |
BOTH |
| Fosaprepitant - Emend |
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 7 MB) |
Statistical (PDF - 662 KB) |
BOTH |
Fosaprepitant - Focinvez
|
Spes Pharmaceuticals Inc.
|
Unireview (PDF - 248 MB)
Unireview (PDF - 1 MB)
|
None |
None |
PREA |
| Fosphenytoin sodium - Cerebyx |
Parke-Davis, a Division of Pfizer, Inc. |
CDTL Review (PDF - 390 KB)
Medical (PDF - 1.5 MB)
|
Clinical pharmacology (PDF - 5 MB) |
None |
BPCA |
| Gadobutrol - Gadavist |
Bayer HealthCare Pharmaceuticals, Inc. |
Medical (PDF - 958KB) |
Clinical pharmacology (PDF -2.2MB) |
Statistical (PDF -422 KB) |
PREA |
| Gadobutrol - Gadavist |
Bayer Healthcare Pharmaceuticals, Inc. |
Medical (PDF - 7MB) |
None |
Statistical (PDF -782 KB) |
PREA |
|
Gadopiclenol - Elucirem
|
Guerbet LLC |
Medical (PDF - 3 MB) |
None |
None |
PREA |
| Gadoterate meglumine - Dotarem |
Guerbet LLC |
Medical (PDF - 3MB) |
Clinical pharmacology (PDF -768KB) |
Statistical (PDF -1.2 MB) |
PREA |
| Gadoterate meglumine - Dotarem |
Guerbet LLC |
Medical (PDF 1.3 MB) |
Clinical pharmacology (PDF - 1.5 MB) |
Statistical (PDF - 398 KB) |
PREA |
| Gadoteridol - ProHance |
Bracco Diagnostics, Inc |
Medical (PDF - 3 MB) |
None |
None |
PREA |
| Gadoxetate disodium - Eovist |
Bayer HealthCare Pharmaceuticals, Inc. |
Medical (PDF -1.2MB) |
Clinical pharmacology (PDF -1.5MB) |
None |
PREA |
| Gatifloxacin ophthalmic solution - Zymar |
Allergan, Inc. |
Medical (PDF - 78 KB) |
None |
None |
BPCA |
| Gatifloxacin - Zymar |
Allergan, Inc. |
DDTL (PDF - 428 KB) |
None |
None |
Both |
|
Gepirone - Exxua
|
Fabre-Kramer Pharmaceuticals, Inc. |
Medical (PDF - 10 MB) |
None |
None |
Both |
| Glecaprevir and Pibrentasvir - Mavyret |
AbbVie Inc. |
CTDL (PDF - 2 MB)
CTDL Addendum (PDF - 187 KB)
|
Clinical pharmacology (PDF - 409 KB) |
Statistical (PDF - 439 KB) |
PREA |
| Glecaprevir and Pibrentasvir - Mavyret |
AbbVie Inc. |
Medical (PDF - 78 KB) |
None |
None |
PREA |
| Glecaprevir and pibrentasvir - Mavyret |
AbbVie, Inc. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 3 MB) |
None |
BOTH |
| Glucagon - Gvoke |
Xeris Pharmaceuticals, Inc. |
Medical (PDF - 3 MB)
CTDL Review (PDF - 3 MB
|
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 2 MB) |
PREA |
| Glucagon - Baqsimi |
Eli Lilly and Company
|
Medical (PDF - 3 MB)
CTDL Review (PDF - 3 MB
|
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 2 MB) |
PREA |
| Glycopyrronium - Qbrexza |
Dermira, Inc. |
Medical (PDF - 6 MB) |
None |
None |
PREA
|
| Golimumab - Simponi |
Janssen Biotech, Inc. |
Medical (PDF - 3.1 MB)
|
Clinical pharmacology (PDF - 307 KB) |
Statistical (PDF - 1.1 MB) |
PREA |
| Golimumab - Simponi Aria |
Janssen Biotech, Inc. |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Guanfacine - Intuniv |
Shire |
Medical (PDF - 2 MB)
CTDL Review (PDF -134 KB)
|
Clinical pharmacology (PDF - 330 KB) |
Statistical (PDF - 544 KB) |
Both |
| Guanfacine - Intuniv |
Shire |
Medical (PDF -3MB) |
Clinical pharmacology (PDF - 667KB) |
Statistical (PDF -3MB) |
PREA |
| Halobetasol - Propionate Ultravate |
Sun Pharmaceutical Industries, Inc. |
Medical (PDF - 150 KB) |
Clinical pharmacology (PDF - 303 KB) |
None |
PREA |
|
Halobetasol Propionate - Lexette
|
Mayne Pharma LLC |
Medical (PDF - 249 KB) |
Clinical pharmacology (PDF - 752 KB) |
None |
BOTH |
| Ibrexafungerp - Brexafemme |
SCYNEXIS, Inc. |
Medical (PDF - 10 MB) |
None |
None |
PREA |
| Ibrexafungerp - Brexafemme |
SCYNEXIS, Inc. |
Medical (PDF - 1 MB) |
None |
None |
PREA |
| Ibrutinib - Imbruvica |
Pharmacyclics LLC
|
Medical (PDF - 20 MB) |
None |
None |
BPCA |
| Ibuprofen - Caldolor |
Cumberland Pharmaceuticals, Inc. |
CTDL Review (PDF -134 KB) |
Clinical pharmacology (PDF - 752 KB) |
None |
PREA |
| Ibuprofen - Caldolor |
Cumberland Pharmaceuticals, Inc. |
DD Summary Review (PDF -669KB)
Medical (PDF -3MB)
|
Clinical pharmacology (PDF -3.7MB) |
Statistical (PDF -378KB) |
PREA |
| IncobotulinumtoxinA - Xeomin |
Merz Pharmaceuticals GmbH |
Medical (PDF - 2 MB) |
None |
Statistical (PDF - 1 MB) |
PREA |
| incobotulinumtoxinA - Xeomin |
Merz Pharmaceuticals GmbH |
Medical (PDF - 1 MB) |
None |
Statistical (PDF - 872 KB) |
PREA |
|
Indocyanine green for Injection - Spy Agent Green
|
Novadaq Technologies ULC |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Infliximab-axxq - Avsola |
Amgen, Inc. |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Infliximab-dyyb - Inflectra |
Celltrion, Inc. |
Medical (PDF -5.3MB)
Addendum (PDF - 1MB)
|
None |
Statistical (PDF -2MB) |
PREA |
| Infliximab-abda - Renflexis |
Samsung Bioepsis Co., Ltd |
CDTL Review (PDF - 1 MB)
Medical (PDF - 3.5 MB)
Medical 2(PDF - 267 KB)
Medical 3 (PDF - 93 KB)
|
Clinical pharmacology (PDF - 7.7 MB) |
Statistical (PDF - 959 KB)
Statistical 2 (PDF - 602 KB)
|
PREA |
| Insulin aspart injection - Fiasp |
Novo Nordisk Inc. |
CDTL Review (PDF - 1 MB)
Medical (PDF - 3.5 MB)
|
Clinical pharmacology (PDF - 4MB) |
Statistical (PDF - 905KB) |
PREA |
| Insulin Degludec - Tresiba |
Novo Nordisk Inc. |
CDTL Review (PDF - 7MB)
Medical (PDF - 7 MB)
|
Clinical pharmacology (PDF - 4MB) |
Statistical (PDF - 905KB) |
PREA |
| Insulin Degludec / Insulin Aspart) - Ryzodeg |
Novo Nordisk Inc. |
Medical (PDF - 7 MB) |
Clinical pharmacology (PDF - 4 MB) |
Statistical (PDF - 905 KB) |
PREA |
|
Insulin glargine-yfgn - Semglee
|
Mylan Pharmaceuticals Inc. |
Medical (PDF - 8 MB) |
None |
None |
PREA |
| Insulin glargine-aglr - Rezvoglar |
Eli Lilly and Company |
Medical (PDF - 2 MB) |
None |
None |
PREA |
Insulin lispro-aabc - Lyumjev
|
Eli Lilly and Company |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 10 MB)
Clinical pharmacology
addendum (PDF - 10 KB)
|
Statistical (PDF - 253 KB) |
PREA |
| Iodixanol - Visipaque |
GE HealthCare Inc.
|
CDTL Review (PDF - 2 MB)
Medical (PDF - 2 MB)
|
Clinical pharmacology (PDF - 988 KB) |
Statistical (PDF - 1.8 MB) |
PREA |
| Iohexol - Oraltag |
Interpharma Praha, a.s. |
Medical (PDF - 91 KB) |
Clinical pharmacology (PDF - 294 KB) |
Statistical (PDF - 98 KB) |
PREA |
| Ipilimumab - Yervoy |
Bristol-Myers Squibb Company |
Medical (PDF 6 MB) |
Clinical pharmacology (PDF - 1.6 MB) |
None |
BPCA |
| Iron Sucrose Injection, USP - Venofer |
Luitpold Pharmaceuticals, Inc. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 114 KB) |
Statistical (PDF - 576 KB) |
PREA |
| Isavuconazonium sulfate - Cresemba |
Astellas Pharma US Inc. |
Medical (PDF - 5 MB) |
None |
None |
BPCA |
| Ivabradine - Corlanor |
Amgen Inc. |
CDTL (PDF - 3 MB)
Medical (PDF - 4 MB)
|
Clinical pharmacology (PDF - 4 MB) |
Statistical (PDF - 51 KB) |
BPCA |
| Ivacaftor - Kalydeco |
Vertex Pharmaceuticals Incorporated |
Medical (PDF - 4 MB) |
None |
None |
BPCA |
| Ixekizumab - Taltz |
Eli Lilly and Company |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol - Technegas |
Cyclomedica Australia Pty Ltd. |
Medical (PDF - 1 MB) |
None |
None |
PREA |
| Kit for the Preparation of Technetium Tc 99m Pentetate Injection - Draximage |
Jubilant DraxImage, Inc
|
Medical (PDF - 2 MB) |
None |
Statistical (PDF - 1 MB) |
PREA |
| Lacosamide - Motpoly XR |
Aucta Pharmaceuticals, Inc. |
Medical (PDF - 276 KB) |
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
| Lacosamide - Vimpat |
UCB, Inc. |
CDTL Review (PDF - 371 KB)
Medical (PDF - 915 KB)
|
Clinical pharmacology (PDF - 2 MB) |
None |
PREA
|
| Lacosamide - Vimpat |
UCB, Inc. |
Medical (PDF - 541 KB)
Medical (PDF - 631 KB)
|
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 2 MB) |
PREA |
| Lacosamide - Vimpat |
UCB, Inc. |
Medical (PDF - 700 KB) |
Clinical pharmacology (PDF - 800 KB) |
None |
PREA |
| Lacosamide - Vimpat |
UCB, Inc. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 9 MB) |
PREA |
| Lactic acid citric acid and K bitartrate - Phexxi |
Evofem, Inc. |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 1 KB) |
Statistical (PDF - 3 76706 KB) |
PREA |
| Lamivudine - Epivir |
ViiV Healthcare Company |
Medical (PDF -4.2 MB) |
Clinical pharmacology (PDF - 3 MB) |
|
PREA |
| Lamivudine and Raltegravir - Dutrebis |
Merck Sharp & Dohme Corp. |
Medical (PDF -1 MB) |
Clinical pharmacology (PDF - 6.4 MB) |
None |
PREA |
| Lamivudine and tenofovir - Cimduo |
Mylan Pharmaceuticals India |
Medical (PDF - 73 KMB) |
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
|
Lamivudine and tenofovir disoproxil fumarate - Temixys
|
Celltrion, Inc. |
Medical (PDF - 20 KB)
|
Clinical pharmacology addendum (PDF - 166 KB)
Clinical pharmacology (PDF - 1 MB)
|
None |
PREA |
| Lamotrigine - Lamictal |
GlaxoSmithKline LLC |
Medical (PDF -18 MB) |
Clinical pharmacology (PDF - 793 KB) |
Statistical (PDF - 1.8 MB) |
PREA |
| Lanadelumab-flyo - Takhzyro |
Takeda Pharmaceuticals U.S.A., Inc. |
Medical (PDF - 7 MB) |
None |
None |
BPCA |
| Ledipasvir-sofosbuvir - Harvoni |
Gilead Sciences, Inc. |
Medical and CDTL (PDF - 1.5 MB) |
Clinical pharmacology (PDF - 539 KB) |
Statistical (PDF - 205 KB) |
PREA |
| Ledipasvir-sofosbuvir - Harvoni |
Gilead Sciences, Inc. |
Medical (PDF - 426 KB) |
None |
None |
BOTH |
| Leuprolide acetate - Fensolvi |
Tolmar, Inc. |
Medical (PDF - 280 KB) |
Clinical pharmacology (PDF - 4 MB |
Statistical (PDF - 2 MB) |
PREA |
| Levalbuterol hydrochloride - Xopenex |
Oak Pharmaceuticals |
Medical (PDF - 8 MB) |
Clinical pharmacology (PDF - 4 MB) |
Statistical (PDF - 2 MB) |
PREA |
| Levalbuterol tartrate - Xopenex HFA |
Sunovion Pharmaceuticals Inc. |
Medical (PDF - 4 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF 1 MB) |
PREA |
| Levamlodipine - Conjupri |
CSPC Ouyi Pharmaceutical Co., Ltd. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 569 KB) |
None |
PREA |
| Levetiracetam - Keppra Extended Release Tablets |
UCB, Inc. |
DD Summary Review (PDF - 202 KB)
CDTL Review (PDF - 371 KB)
Medical (PDF - 327 KB)
|
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
| Levomilnacipran - Fetzima |
AbbVie Inc. |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Levonorgestrel - Liletta |
Medicines360 |
Medical (PDF - 9 MB) |
Clinical pharmacology (PDF - 1 MB)
Clinical pharmacology (PDF - 2 MB)
|
Statistical (PDF - 2 MB) |
PREA |
| Levonorgestrel/ethinyl estradiol tablets |
Exeltis |
CDTL (PDF - 9 MB)
Medical (PDF - 9 MB)
Medical (PDF - 9 MB)
|
Clinical pharmacology (PDF - 1 MB)
Clinical pharmacology (PDF - 4 MB)
|
Statistical (PDF - 1.5 MB) |
PREA |
| Levonorgestrel/ethinyl estradiol and ethinyl estradiol - Quartette |
Teva Branded Pharmaceutical Products R&D, Inc. |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 4 MB)
Clinical pharmacology addendum (PDF - 89KB)
|
Statistical (PDF - 1MB) |
PREA |
| Levonorgestrel-releasing intrauterine system - Skyla |
Bayer HealthCare Pharmaceuticals, Inc. |
Medical (PDF - 8MB) |
Clinical pharmacology (PDF - 4MB) |
Statistical (PDF - 424 KB) |
PREA |
|
Levonorgestrel releasing intrauterine system - Liletta
|
Medicines360 |
CDTL Review (PDF - 179KB)
Medical (PDF - 2 MB)
|
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 168 KB) |
PREA |
|
Levonorgestrel - Mirena
|
Bayer HealthCare Pharmaceuticals, Inc. |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Levothyroxine sodium oral solution - Tirosint-SOL |
Cromsource, Inc. |
CDTL Review (PDF - 461 KB)
Medical (PDF - 3 MB)
|
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Linaclotide - Linzess |
AbbVie Inc. |
Medical (PDF - 3 MB) |
None |
None |
BOTH |
| Linagliptin and Metformin Hydrochloride - Jentadueto XR |
Boehringer Ingelheim Pharmaceuticals, Inc. |
Medical (PDF - 7 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 246 KB) |
BOTH |
| Linagliptin and Metformin hydrochloride - Tradjenta |
Boehringer Ingelheim Pharmaceuticals, Inc. |
Medical (PDF - 7 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 246 KB) |
BOTH |
| Linagliptin - Tradjenta |
Boehringer Ingelheim Pharmaceuticals, Inc |
Medical (PDF - 7 MB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 2 MB) |
BOTH |
| Lipid injectable emulsion - SMOFlipid |
Fresenius Kabi USA, LLC |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
|
Liraglutide - Saxenda
|
Novo Nordisk, Inc. |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 5 MB) |
Statistical (PDF - 2 MB) |
PREA |
| Liraglutide - Victoza |
Novo Nordisk Inc. |
Medical (PDF - 8 MB) |
Clinical pharmacology (PDF - 864 KB) |
Statistical (PDF - 450 KB) |
BOTH |
| Lisdexamfetamine dimesylate - Vyvanse |
Shire Development, LLC |
Medical (PDF - 218 KB) |
Clinical pharmacology (PDF - 1 MB) |
None |
BOTH |
| Lisdexamfetamine mesylate - Vyvanse |
Shire |
Medical (PDF - 2 MB) |
None |
Statistical (PDF - 1 MB) |
PREA |
|
Lisdexamfetamine dimesylate - Vyvanse
|
Takeda Pharmaceuticals U.S.A., Inc. |
Medical (PDF - 804 KB) |
None |
None |
BOTH |
Lisenatide - Adlyxin
|
Sanofi-aventis U.S. LLC |
Medical (PDF - 182 KB) |
Clinical pharmacology (PDF - 1 MB) |
None |
BOTH |
Lumacaftor and ivacaftor - Orkambi
|
Vertex Pharmaceuticals Incorporated |
Medical (PDF - 6 MB) |
None |
None |
BPCA |
| Loteprednol - Lotemax |
Bausch & Lonb Inc. |
Medical (PDF - 318 KB)
Medical (PDF - 218 KB)
|
None |
Statistical (PDF - 3 MB) |
PREA |
| Luliconazole - LuzuTM |
Medicis Pharmaceutical Corporation, a division of Valeant Pharmaceuticals NA LLC |
CDTL (PDF - 358 KB)
CDTL (PDF - 372 KB)
Medical (PDF - 306 KB)
Medical (PDF - 616 KB)
|
Clinical pharmacology (PDF -1 MB)
Clinical pharmacology (PDF - 423 KB)
|
Statistical (PDF - 207 KB) |
PREA |
| Lopinavir / Ritonavir - Kaletra |
AbbVie Inc. |
Medical (PDF - 5.8 MB) |
Clinical pharmacology (PDF -2.3 MB) |
Statistical (PDF - 2 MB) |
PREA |
| Lubiprostone - Amitizia |
Sucampo Pharmaceuticals Inc. |
Medical (PDF - 11 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 1 MB) |
PREA |
| Lutetium Lu177 dotatate - Lutathera |
Advanced Accelerator Applications USA, Inc. |
Medical (PDF - 3 MB) |
None |
None |
BPCA |
| Lurasidone hydrochloride - Latuda |
Sunovion Pharmaceuticals, Inc. |
Medical (PDF - 6 MB)
Medical (PDF - 7 MB)
|
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 369 KB)
Statistical (PDF - 255 KB)
|
BOTH |
| Lurasidone hydrochloride - Latuda |
Sunovion Pharmaceuticals, Inc. |
CDTL (PDF - 6 MB)
Medical (PDF - 6 MB)
|
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 368 KB) |
PREA |
| Lurasidone hydrochloride - Latuda |
Sunovion Pharmaceuticals, Inc. |
Medical (PDF - 1 MB) |
None |
None |
PREA |
| Maraviroc - Selzentry |
Viiv Healthcare |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 3 MB) |
None |
PREA |
| Maraviroc - Selzentry |
Viiv Healthcare |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 3 MB) |
None |
BPCA |
| Memantine hydrochloride - Namenda XR |
Forest Research Institute, Inc. (subsidiary of Forest Laboratories Inc.) |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 956 KB) |
Statistical (PDF - 1 MB) |
BPCA |
| Mepolizumab - Nucala |
GlaxoSmithKline LLC |
Medical (PDF - 8 MB) |
Clinical pharmacology (PDF - 6 MB)
Clinical pharmacology addendum (PDF - 425 KB)
|
Statistical (PDF - 1 MB) |
PREA |
| Mepolizumab - Nucala |
GlaxoSmithKline LLC |
Medical(PDF - 8 MB) |
None |
None |
PREA |
| Mepolizumab - Nucala |
GlaxoSmithKline LLC |
Medical (PDF - 8 MB) |
None |
None |
PREA |
| Mirabegron - Myrbetriq |
Astellas Pharma Global Development, Inc. |
Medical (PDF - 13 MB) |
Clinical pharmacology (PDF - 3 MB)
|
Statistical (PDF - 168KB) |
BOTH |
| Mesalamine - Asacol HD |
Warner Chilcott |
Medical (PDF - 6 MB) |
Clinical pharmacology (PDF - 3 MB)
Clinical pharmacology (PDF - 518 KB)
|
Statistical (PDF -499 KB) |
PREA |
| Mesalamine - Canasa |
Forest Laboratories |
Medical (PDF - 6 MB) |
Clinical pharmacology (PDF - 251 KB) |
Statistical (PDF - 344 KB) |
PREA |
| Mesalamine - Delzicol |
Warner Chilcott LLC |
Medical (PDF - 707 KB)
Medical Addendum(PDF - 495 KB)
|
Clinical pharmacology (PDF - 116 KB) |
None |
PREA |
| Mesalamine - Delzicol |
Warner Chilcott (US), LLC |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 729 KB) |
Statistical (PDF - 1 KB) |
PREA |
| Mesalamine - Lialda |
Shire Development, LLC |
Medical (PDF - 6 MB) |
None |
None |
PREA |
|
Metformin hydrochloride for extended-release oral suspension - Riomet ER
|
Pharmaceutical Industries Limited |
CTDL Review (PDF - 917 KB) |
Clinical pharmacology (PDF - 818 KB) |
None |
PREA |
| 10% Methyl salicylate, 3% L-menthol - Salonpas Pain Relief |
Hisamitsu Pharmaceutical Co., Inc. |
Medical (PDF - 998 KB)
Medical (PDF - 3 MB)
|
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 1 MB) |
PREA |
|
Methylphenidate hydrochloride extended-release - Aptensio XR
|
Rhodes Pharmaceuticals L.P. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 4 MB) |
Statistical (PDF - 1 MB)
Statistical (PDF - 629 KB) |
PREA |
| Methylphenidate hydrochloride - Aptensio XR |
Rhodes Pharmaceuticals L.P. |
CTDL Review (PDF - 592 KB)
Medical (PDF - 3 MB)
|
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 1 MB)
Statistical (PDF - 139 KB)
|
BOTH |
| Methylphenidate hydrochloride - Quillivant XR |
NextWave Pharmaceuticals, Inc. |
Medical (PDF - 26 KB) |
Clinical pharmacology (PDF - 588 KB) |
Statistical (PDF - 380 KB) |
PREA |
| Methylphenidate hydrochloride extended release chewable tablets - QuilliChew ER |
Pfizer Inc. |
CTDL Review (PDF -1 MB)
Medical (PDF - 5 MB)
|
Clinical pharmacology (PDF -2.9MB) |
Statistical (PDF -498KB) |
PREA |
|
Methylphenidate HCL extended-release capsules - Adhansia XR
|
Purdue Pharma
|
Medical (PDF - 2 MB)
Medical (PDF - 5 MB)
|
Clinical pharmacology (PDF - 2 MB)
|
Statistical (PDF - 1 MB)
Statistical (PDF - 2 MB)
|
PREA |
|
Methylphenidate hydrochloride - Jornay PM
|
Ironshore Pharmaceuticals & Development, Inc. |
Medical (PDF - 4.8 MB) |
Clinical pharmacology (PDF - 2.1 MB) |
Statistical (PDF - 921 KB) |
PREA |
| Methylphenidate extended-release orally disintegrating tablets - Cotempla XR-ODT |
Neos Therapeutics, Inc. |
Medical (PDF - 5.7 MB)
Medical (PDF - 1.2 MB)
|
Clinical pharmacology (PDF - 2.1 MB)
Clinical pharmacology (PDF - 2.1 MB)
|
Statistical (PDF - 921 KB)
Statistical (PDF - 96 KB)
|
PREA |
| Methoxy polyethylene glycol-epoetin beta - Mircera |
Vifor International AG |
Medical (PDF - 2.3 MB)
|
None |
Statistical (PDF - 239 KB)
|
PREA |
| Methoxy polyethylene glycol-epoetin beta - Mircera |
Vifor (International) AG c/o ProPharma Group |
Medical (PDF - 7 MB) |
Clinical Pharmacology (PDF - 5MB) |
Statistical (PDF - 7 MB) |
PREA |
| Metoprolol Succinate - KAPSPARGO SPRINKLE |
Sun Sun Pharmaceutical Industries LimitedPharmaceutical Industries Limited |
Medical (PDF - 799 KB) |
Clinical pharmacology (PDF - 978 KB) |
None |
PREA |
| Metronidazole - Likmez |
Saptalis Pharmaceuticals, LLC |
Medical (PDF - 6 MB) |
None |
None |
PREA |
| Metronidazole vaginal gel 1.3% - Nuvessa |
Chemo Research SL |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 70 KB) |
Statistical (PDF - 127 KB) |
PREA |
| Micafungin for injection - Mycamine |
Astellas Pharma US, Inc. |
Medical (PDF - 1 MB) |
None |
None |
BOTH |
|
Micafungin in Sodium Chloride Injection - Micafungi
|
Baxter HealthCare Corporation |
Medical (PDF - 1 MB) |
None |
None |
PREA |
| Micafungin sodium - Mycamine |
Astellas Pharma US, Inc. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 4.4MB)
|
Statistical (PDF -987KB) |
BPCA |
Minocycline - Amzeeq
|
Foamix Pharmaceuticals Inc. |
Medical (PDF - 2.2 MB) |
None |
None |
PREA |
| Mirabegron extended-release tablets and mirabegron extended-release for oral suspension - Myrbetriq and Myrbetriq Granules |
Astellas Pharma Global Development, Inc. |
Medical (PDF - 13 MB) |
None |
None |
BOTH |
| Mixed salts of a single-entity amphetamine product - Mydayis |
Shire Development, LLC. |
Medical (PDF - 7 MB)
|
Clinical pharmacology (PDF -1.8KB) |
Statistical (PDF -987KB) |
PREA |
| Mixed salts of a single entity amphetamine product - Mydayis |
Shire Development, LLC. |
Medical (PDF - 7 MB) |
None |
None |
BPCA |
| Mometasone furoate - Asmanex HFA |
Merck Sharp & Dohme Corp. |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF -2 MB) |
Statistical (PDF -603KB) |
PREA |
| Mometasone furoate - Asmanex HFA |
Merck Sharp & Dohm Corp |
Medical (PDF- 1 MB) |
None |
None |
PREA |
| Mometasone furoate - Asmanex HFA |
Merck Sharp & Dohm Corp |
Medical (PDF - 1 MB) |
None |
None |
PREA |
| Mometasone furoate and formoterol fumarate - Dulera |
Schering-Plough |
Medical (PDF- 1 MB) |
None |
None |
PREA |
| Morphine sulfate - Morphine sulfate |
Hospira, Inc. |
Medical (PDF - 1 MB) |
None |
None |
PREA |
| Morphine sulfate - Morphine sulfate |
Hikma Pharmaceuticals USA Inc. |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 3 MB) |
None |
PREA |
|
Moxifloxacin - Avelox
|
Bayer Pharmaceuticals |
Medical (PDF- 905 KB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 760 KB) |
PREA |
| Moxifloxacin ophthalmic solution - Vigamox |
Alcon Pharmaceuticals, Ltd. |
Medical (PDF - 434 KB)
DD Summary Review (PDF- 118 KB)
|
None |
None |
BPCA |
Mycophenolate mofetil - CellCept
|
Roche Palo Alto LLC |
Medical (PDF - 6 MB) |
None |
None |
PREA |
| Naftifine hydrochloride - Naftin |
Merz Pharmaceuticals, LLC |
Medical (PDF - 488 KB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 188 KB) |
PREA |
| Naftifine hydrochloride - Naftin Cream, 2% |
Merz Pharmaceuticals, LLC |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 822 KB) |
PREA |
| Nalmefene - Opvee |
Opiant Pharmaceuticals, Inc. |
CTDL Review (PDF - 4 MB)
|
Clinical pharmacology (PDF - 9 MB)
Clinical pharmacology addendum (PDF - 9 KB)
|
Statistical (PDF - 2 MB) |
PREA |
| Naloxone hydrochloride - Kloxxado
|
Hikma Pharmaceuticals USA, Inc. |
CTDL Review (PDF - 613 KB)
CTDL and DD Review (PDF - 1 MB)
Medical (PDF - 4 MB)
|
None |
None |
PREA |
| Naloxone hydrochloride - Narcan Nasal Spray |
Adapt Pharma Operations Limited |
DD Summary Review(PDF -1 MB)
CTDL Review (PDF - 3 MB)
|
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Naloxone Hydrochloride Injection - Naloxone Hydrochloride Injection |
Kaleo, Inc. |
CDTL Review (PDF - 2 MB) |
Clinical pharmacology (PDF - 4 MB) |
None |
PREA |
| Naloxone Hydrochloride - Rextovy |
Amphastar Pharmaceuticals, Inc |
Medical (PDF - 3 MB)
CDDD Review (PDF - 637 KB)
|
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Naloxone Hydrochloride - Rezenopy |
Summit Biosciences |
Medical (PDF - 2MB)
CDTL Review (PDF - 3MB)
|
Clinical pharmacology (PDF - 1MB) |
None |
PREA |
| Naloxone hydrochloride - RiVive |
Harm Reduction Therapeutics, Inc. |
Medical (PDF - 2 MB) |
None |
None |
PREA |
|
Naloxone hydrochloride - Zimhi
|
Adamis Pharmaceuticals Corporation |
CDTL Review (PDF - 2 MB) |
Clinical pharmacology (PDF - 368 KB) |
None |
PREA |
| Naproxen sodium 220 mg and Diphenhydramine hydrochloride - Aleve PM |
Bayer HealthCare, LLC – Consumer Care |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF -1 MB) |
PREA |
| Naproxen and esomeprazole magnesium - Vimovo |
Horizon Pharma Inc. |
Medical (PDF - 4 MB) |
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Neostigmine methylsulfate - Bloxiverz |
Eclat Pharmaceuticals, LLC |
Medical (PDF - 8 MB) |
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Neostigmine methylsulfate and glycopyrrolate - Prevduo |
Slayback Pharma LLC |
CDTL Review (PDF - 794 KB) |
Clinical pharmacology (PDF - 284 KB) |
None |
PREA |
| Nevirapine - Viramune XR |
Boehringer Ingelheim Pharmaceuticals, Inc. |
Medical (PDF -2MB) |
Clinical pharmacology (PDF - 446 KB) |
Statistical (PDF - 723KB) |
PREA |
| Nilotinib - Tasigna |
Sponsor: Novartis Pharmaceuticals Corporation |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 1.6 MB) |
Statistical (PDF - 124 KB) |
BPCA |
| Nintedanib - Ofev |
Boehringer Ingelheim Pharmaceuticals, Inc. |
Medical (PDF - 10 MB) |
None |
None |
BPCA |
| Nirmatrelvir - Ritonavir - Paxlovid |
Pfizer, Inc |
Medical (PDF - 27 MB) |
None |
None |
PREA |
| Nirsevimab-alip - Beyfortus |
AstraZeneca AB |
Medical (PDF - 20 MB) |
None |
None |
PREA |
| Nitisinone - NITYR |
Cycle Pharmaceuticals Ltd. |
Medical (PDF - 358 KB) |
Clinical pharmacology (PDF - 4 MB) |
None |
PREA |
| Nitisinone - NITYR |
Cycle Pharmaceuticals Ltd. |
Medical (PDF - 358 KB) |
None |
None |
PREA |
Nivolumab - Opdivo
|
Bristol-Myers Squibb Company
|
DD (PDF - 188 KB)
Medical (PDF - 222 KB)
|
Clinical pharmacology (PDF - 202 KB)
Clinical pharmacology (PDF - 250 KB)
|
Noen |
PREA |
| Nivolumab - Opdivo |
Bristol-Myers Squibb Company |
Medical (PDF - 8 MB) |
None |
None |
BPCA |
| Nivolumab - Opdivo |
Bristol-Myers Squibb Company |
Medical (PDF - 11 MB) |
None |
None |
BPCA |
|
Nivolumab and relatlimab-rmbw - Opdualag
|
Bristol-Myers Squibb Company |
Medical (PDF - 29 MB) |
None |
None |
PREA |
| Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules - Taytulla |
Warner Chilcott Company, LLC |
Medical (PDF -1MB) |
Clinical pharmacology (PDF -3.2MB) |
Statistical (PDF - 469 KB) |
PREA |
| Obiltoxaximab - Anthim |
Elusys Theraputics, Inc. |
Medical (PDF -18 MB)
Addendum (PDF - 249 KB)
|
Clinical pharmacology (PDF -12MB)
Addendum (PDF -126 KB)
|
Statistical (PDF - 9 MB) |
PREA |
| Ocriplasmin- Jetrea |
ThromboGenics, Inc. |
Medical (PDF - 817 KB) |
Clinical pharmacology (PDF - 117KB) |
Statistical (PDF - 760 KB) |
PREA |
| Olanzapine and fluoxetine hydrochloride - Symbyax |
Eli Lilly and Company |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF -1.2MB)
Addendum (PDF - 132KB)
|
Statistical (PDF - 953 KB) |
PREA |
| Olopatadine - Pazeo |
Alcon Research LTD |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF -340KB) |
Statistical (PDF - 4 KB) |
BOTH |
| Olopatadine hydrochloride and mometasone furoate - Ryaltris |
Glenmark Specialty SA |
Medical (PDF - 6 MB)
CDTL (PDF - 6 MB)
|
None |
None |
PREA |
| Omalizumab - Xolair |
Genentech |
Medical (PDF - 6 MB) |
Clinical pharmacology (PDF -1.3MB) |
Statistical (PDF - 2MB) |
PREA |
| Omalizumab - Xolair |
Genentech, Inc. and Novartis Pharmaceuticals Corp. |
Medical (PDF- 4 MB) |
Clinical pharmacology (PDF -1MB) |
Statistical (PDF - 1 MB) |
PREA |
|
Omalizumab - Xolair
|
Genentech, Inc. and Novartis Pharmaceuticals Corp. |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Omalizumab - Xolair |
Genentech, Inc. |
Medical (PDF - 8 MB) |
None |
None |
PREA |
| Omeprazole magnesium - Prilosec |
AstraZeneca Pharmaceuticals LP |
Medical (PDF - 908 KB) |
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
|
OnabotulinumtoxinA - Botox
|
Allergan, Inc. |
CDTL (PDF - 403 KB)
Medical (PDF - 1 MB)
|
None |
Statistical (PDF - 173 KB) |
PREA |
| OnabotulinumtoxinA - Botox |
Allergen, Inc |
Medical (PDF - 3 MB)
Medical (PDF - 1 MB)
|
None |
Statistical (PDF - 1 MB) |
PREA |
| OnabotulinumtoxinA - Botox |
Allergen, Inc |
Medical (PDF - 1 MB) |
None |
None |
PREA |
OnabotulinumtoxinA - Botox
|
Allergan, Inc. |
Medical (PDF - 1 MB) |
None |
Statistical (PDF - 2 MB) |
PREA |
OnabotulinumtoxinA - Botox
|
Allergan, Inc. |
Medical (PDF - 3 MB) |
None |
None |
PREA |
| Oxaprozin - Coxanto |
Solubiomix, Inc. |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Oxcarbazepine - Oxtellar XR |
Supernus Pharmaceuticals, Inc. |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 7 MB) |
Statistical (PDF - 482 KB) |
PREA |
| Oxycodone hydrochloride - Oxycodone hydrochloride |
Genus Lifesciences, Inc. |
Medical (PDF - 2 MB)
DD Memo (PDF - 1 MB)
|
Clinical pharmacology (PDF - 688 KB) |
None |
PREA |
| Oxycodone hydrochloride - Oxycontin |
Purdue Pharma L.P. |
Medical (PDF - 17 MB) |
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 678 KB) |
BPCA |
| Oxymorphone - Opana |
|
Medical (PDF - 17 MB) |
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Ozenoxacin - Xepi |
Ferrer Internacional S.A. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 524 KB) |
PREA |
| Paclitaxel - Abraxane |
Abraxis BioScience, L.L.C., a wholly-owned subsidiary of Celgene Corporation |
Medical (PDF - 235 KB) |
None |
None |
BPCA |
| Palifermin - Kepivance |
Quintiles, Inc. |
Medical (PDF - 280 KB) |
Clinical pharmacology (PDF - 726 KB) |
None |
PREA |
| Palonosetron hydrochloride - Aloxi |
Helsinn Healthcare SA |
Medical (PDF - 15 MB)
Medical (PDF - 2 MB)
|
Clinical pharmacology (PDF -2 MB) |
Statistical (PDF - 771 KB) |
BOTH |
| Pancrelipase - Creon |
AbbVie Inc. |
Medical (PDF - 566 KB) |
None |
None |
PREA |
| Pancrelipase - Pancreaze |
Janssen Pharmaceuticals, Inc. |
Medical (PDF - 142 KB) |
None |
None |
PREA |
| Pancrelipase - Pertzye |
Digestive Care, Inc. |
Medical (PDF - 1 MB) |
None |
None |
PREA |
| Pancrelipase - Zenpep |
Aptalis Pharma Limited. |
Medical (PDF - 587 KB) |
None |
None |
PREA |
| Paricalcitol - Zemplar |
AbbVie Inc. |
Medical (PDF - 3 MB)
CDTL (PDF - 1 MB)
|
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 427 KB) |
PREA |
| Patiromer - Veltassa |
Vifor Pharma, Inc. |
Medical (PDF - 3 MB) |
None |
None |
PREA |
|
Pegfilgrastim-cbqv - UDENYCA
|
Coherus BioSciences, Inc
|
Medical (PDF - 184 KB)
Medical (PDF - 228 KB)
CDTL (PDF - 584 KB)
|
Clinical pharmacology (PDF - 968 KB) |
Statistical (PDF - 199 KB) |
PREA |
| Pegfilgrastim-fpgk - Stimufend |
Fresenius Kabi USA, LLC |
CDTL (PDF - 198 KB) |
None |
None |
PREA |
| Pegfilgrastim-bmez - Ziextenzo |
Sandoz Inc. |
CDTL (PDF - 348 KB) |
None |
None |
PREA |
| Peginterferon alfa-2a - Pegays |
Hoffmann-La Roche, Incorporated |
Medical (PDF - 799 KB) |
Clinical pharmacology (PDF - 667 KB) |
Statistical (PDF - 667 KB) |
PREA |
| Peramivir - Rapivab |
BioCryst Pharmaceuticals, Inc. |
Medical (PDF - 767 KB |
Clinical pharmacology (PDF -468 KB) |
Statistical (PDF - 767KB) |
PREA |
Peramivir - Rapivab
|
BioCryst Pharmaceuticals, Inc. |
Medical (PDF - 1 MB |
Clinical pharmacology (PDF - 81 KB) |
None |
PREA |
| Perampanel - Fycompa |
Eisai, Inc. |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF -6MB) |
Statistical (PDF -1.2MB) |
PREA |
| Perampanel - Fycompa |
Eisai, Inc. |
Medical (PDF - 3 MB)
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF -4MB) |
Statistical (PDF -1.3MB) |
PREA |
| Perampanel - Fycompa |
Eisai Inc. |
Medical (PDF - 3 MB)
Medical MTL (PDF - 678 KB)
|
Clinical pharmacology (PDF -1.2MB) |
None |
PREA |
| Perampanel - Fycompa |
Eisai Inc. |
Medical (PDF - 79 KB) |
Clinical pharmacology (PDF - 86 KB) |
None |
PREA |
|
Perampanel - Fycompa
|
Eisai Inc.
|
CDTL (PDF - 452 KB)
Medical (PDF - 5 MB)
|
Clinical pharmacology (PDF - 2.5 MB) |
None |
PREA |
Perflutren lipid microsphere - DEFINITY and DEFINITY RT
|
Lantheus Medical Imaging, Inc. |
Medical (PDF - 719 KB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 858 KB) |
PREA |
|
Pentermine and topiramate - Qsymia
|
VIVUS LLC |
Medical (PDF - 9 MB) |
Clinical pharmacology (PDF - 587 KB) |
Statistical (PDF - 858 KB) |
PREA |
| Phentolamine mesylate - OraVerse |
Septodont Holding Sas |
Medical (PDF - 3 MB) |
None |
Statistical (PDF - 1 MB) |
PREA |
| Phenylephrine hydrochloride ophthalmic solution |
Paragon BioTeck, Inc. |
Medical (PDF - 1MB) |
Clinical pharmacology (PDF - 95 KB) |
Statistical (PDF -1 MB) |
PREA |
|
Phentolamine ophthalmic solution - Ryzumvi
|
Ocuphire Pharma, Inc. |
CDTL (PDF - 1 MB)
Medical (PDF - 1 MB)
|
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
| Phenylephrine and ketorolac - Omidria |
Omeros Corporation |
CDTL (PDF - 1 MB)
Medical (PDF - 4 MB) |
None |
Statistical (PDF - 816 KB) |
BPCA |
| Piperacillin and tazobactam - Zosyn |
Wyeth Pharmaceuticals LLC |
Medical (PDF - 2 MB) |
None |
None |
PREA |
|
Pitavastatin - Livalo
|
Kowa Pharmaceuticals America, Inc. |
CDTL Review (PDF - 526 KB)
Medical (PDF - 2 MB)
|
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 240 KB) |
BPCA |
| Pomalidomide - POMALYST |
Celgene Corporation |
Medical (PDF - 15 KB) |
Clinical pharmacology (PDF - 1 MB) |
None |
BPCA |
| Posaconazole - Noxafil |
Merck Sharp & Dohme Corp. |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 252KB) |
PREA |
| Posaconazole - Noxafil |
Merck |
Medical (PDF - 602 KB) |
Clinical pharmacology (PDF - 645 KB) |
None |
PREA |
| Posaconazole - Noxafil |
Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc. |
Medical (PDF - 8 MB) |
None |
None |
PREA |
| Potassium phosphate |
Fresenius Kabi USA, LLC |
Medical (PDF - 602 KB) |
None |
None |
PREA |
| Potassium Phosphates - Potassium Phosphates NEW
|
CMP Development LLC |
Medical (PDF - 3 MB) |
None |
None |
PREA |
| Prasugrel - Effient |
Eli Lilly and Company |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 911 KB) |
Statistical (PDF -290 KB) |
BPCA |
| Pregabalin - Lyrica |
Pfizer |
Medical (PDF - 4 MB) |
Clinical pharmacology (PDF - 6 KB) |
Statistical (PDF - 825 KB) |
PREA |
| Pregabalin - Lyrica |
PF PRISM CV |
Medical and Statistical (PDF - 1 MB) |
Clinical pharmacology (PDF - 1.3 MB) |
Medical and Statistical (PDF - 1 MB) |
PREA |
| Pregabalin - Lyrica |
Pfizer |
CTDL Review (PDF - 1 MB)
Medical (PDF - 1 MB)
|
Clinical pharmacology(PDF -1 MB) |
Statistical (PDF - 2 MB) |
BOTH |
| Quetiapine fumarate - Seroquel and Seroquel XR |
AstraZeneca Pharmaceuticals LP |
CTDL Review (PDF - 1 MB)
Medical (PDF - 3 MB)
|
Clinical pharmacology (PDF - 2 MB)
Clinical pharmacology (PDF - 739 KB)
|
Statistical (PDF - 785 KB) |
PREA |
| Rabeprazole sodium - AcipHex Sprinkle |
Eisa Inc. |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 5 MB) |
Statistical (PDF 185 KB) |
BOTH |
|
Ramucirumab - Cyramza
|
Eli Lilly and Company |
Medical (PDF - 198 KB) |
Clinical pharmacology (PDF - 168 KB) |
None |
BPCA |
| Raltegravir - Isentress |
Merck Sharp Dohme Corp |
Medical (PDF - 1MB) |
Clinical pharmacology (PDF - 2 MB) |
None |
PREA |
| Raltegravir - Isentress |
Merck Sharp Dohme Corp |
CDTL Review (PDF - 5 MB) |
Clinical pharmacology (PDF - 5 MB) |
Statistical (PDF 874 KB) |
PREA |
| Raltegravir - Isentress |
Merck Sharp Dohme Corp |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 1 MB) |
None |
BOTH |
|
Ravulizumab-cwvz - Ultomiris
|
Alexion Pharmaceuticals, Inc. |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Remdesivir - Veklury |
Gilead Sciences, Inc.
|
Medical (PDF - 1 MB)
Medical (PDF - 776 KB)
|
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 225 KB)
Statistical (PDF - 782 KB)
|
PREA |
Remdesivir - Veklury
|
Gilead Sciences, Inc. |
CDTL (PDF - 3 MB) |
None |
None |
PREA |
Remdesivir - Veklury
|
Gilead Sciences, Inc. |
CDTL (PDF - 3 MB) |
None |
None |
PREA |
| Remdesivir - Veklury |
Gilead Sciences, Inc. |
CDTL (PDF - 4 MB) |
None |
None |
BOTH |
| Reslizumab - Cinqair |
Teva Respiratory, LLC |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 9 MB) |
Statistical (PDF - 2 MB) |
PREA |
| Rifapentin - Priftin |
Sanofi US Services Inc. |
Medical (PDF - MB) |
Clinical pharmacology (PDF - 5 MB) |
Statistical (PDF - 3 MB) |
PREA |
| Rilpivirine - Edurant |
Janssen Products L.P. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF -138 KB) |
None |
PREA |
| Rilpivirine - Edurant |
Janssen Products L.P. |
Medical (PDF - 41 MB) |
Clinical pharmacology (PDF - 2 MB)
Clinical pharmacology (PDF - 235 KB)
|
|
PREA |
| Rilpivirine - Edurant |
Janssen Products, LP |
Medical (PDF - 9 MB) |
None |
None |
BPCA |
| Rivaroxaban - Xarelto |
Janssen Pharmaceuticals, Inc. |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 10 MB) |
Statistical (PDF - 797 KB) |
BOTH |
| Risperidone - Risperdal Consta |
Janssen Pharmaceuticals, Inc. |
DD Summary Review (PDF - 20 KB)
CTDL Review (PDF - 1MB)
Medical (PDF - 670KB)
Medical (PDF - 667 KB)
|
None |
Statistical (PDF - 237KB) |
PREA |
| Ritlecitinib - Litfulo |
Pfizer, Inc. |
Medical (PDF - 15 MB) |
None |
None |
PREA |
|
Rituximab-arrx - Riabni
|
Amgen, Inc. |
Medical (PDF - 7 MB) |
None |
None |
PREA |
| Rizatriptan - RizaFilm |
IntelGenx Corp. |
Medical (PDF - 352 KB)
Memo (PDF - 851 KB)
|
Clinical pharmacology (PDF - 220 KB) |
None |
PREA |
| Roflumilast - Zoryeve |
Arcutis Biotherapeutics, Inc. |
Medical (PDF - 6 MB) |
None |
None |
PREA |
|
Roflumilast - Zoryeve
|
Arcutis Biotherapeutics, Inc. |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 3 MB) |
None |
PREA |
| Roflumilast - Zoryeve |
Arcutis Biotherapeutics, Inc. |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Rosuvastatin - Ezallor Sprinkle |
Sun Pharmaceutical Industries Limited |
Medical (PDF - 27 KB) |
None |
None |
PREA |
| Rufinamide - Banzel |
Eisai Inc. |
Medical (PDF - 10 MB) |
Clinical pharmacology (PDF - 3MB) |
None |
BPCA |
| Ruxolitinib - Jakafi |
Incyte Corporation
|
Medical (PDF - 685 KB) |
Clinical pharmacology (PDF - 533 KB) |
None |
BPCA |
| Ruxolitinib - Jakafi |
Incyte Corporation |
Medical (PDF - 685 KB) |
None |
None |
BPCA |
|
Ruxolitinib - Opzelura
|
Incyte Corporation |
Medical (PDF - 9 MB) |
None |
None |
PREA |
| Ruxolitinib - Opzelura |
Incyte Corporation |
Medical (PDF - 7 MB) |
None |
None |
PREA |
| Sacubitril-valsartan - Entresto |
Novartis Pharmaceuticals Corp. |
Medical (PDF - 685 KB) |
Clinical pharmacology (PDF - 533 KB) |
Statistical (PDF -1MB) |
BPCA |
| Sacubitril-valsartan - Entresto |
Novartis Pharmaceuticals Corp. |
CDTL (PDF - 727 KB)
Medical (PDF - 9 MB)
|
Clinical pharmacology (PDF - 6 MB) |
None |
PREA |
| Sapropterin dihydrochloride - Kuvan |
BioMarin Pharmaceutical Inc. |
Medical (PDF - 4 MB) |
Clinical pharmacology (PDF -3 MB) |
None |
BPCA |
| Saquinavir mesylate - Invirase |
Hoffmann La-Roche, Inc.orporated c/o Genentech, Inc. |
Medical (PDF -1 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF -1MB) |
BOTH |
|
Sarecycline - Seysara
|
Allergan, Inc. |
Medical (PDF -1 MB) |
None |
None |
PREA |
| Secnidazole - Solosec |
Lupin Pharmaceuticals, Inc. |
Medical (PDF 4 MB) |
None |
None |
PREA |
| Secnidazole - Solosec |
Lupin Pharmaceuticals, Inc. (A subsidiary of Lupin Inc.) |
Medical (PDF 2 MB) |
None |
None |
PREA |
|
Secukinuma - Cosentyx
|
Novartis Pharmaceuticals Corporation |
Medical (PDF - 6 MB) |
None |
None |
PREA |
| Selegiline - Emsam |
Somerset Pharmaceuticals |
Medical (PDF -1 MB)
Medical 2 (PDF -1 MB)
Medical Secondary 1 (PDF - 349 KB)
Medical Secondary 2 (PDF -188 KB)
|
None |
None |
PREA |
| Selenious Acid - Selenious Acid |
American Regent, Inc. |
Medical (PDF - 8 MB) |
None |
None |
PREA |
| Selenious Acid - Selenious Acid |
American Regent, Inc. |
Medical (PDF - 8 MB) |
None
|
None |
PREA |
| Segesterone acetate and ethinyl estradiol vaginal systems - Annovera |
The Population Council, Inc. |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Semaglutide - Wegovy |
Novo Nordisk Inc. |
Medical (PDF - 8 MB)
|
Clinical pharmacology (PDF - 16 MB) |
Statistical (PDF - 869 KB) |
PREA |
| Serdexmethylphenidate and dexmethylphenidate - Azstarys |
Commave Therapeutics |
Multidisciplinary (PDF - 7 MB) |
None |
None |
PREA |
| Sevelamer Carbonate - Renvela |
Genzyme/Sanofi |
Medical (PDF - 745 KB) |
Clinical pharmacology (PDF - 542 KB) |
Statistical (PDF - 541KB) |
PREA |
|
Sitagliptin - Januvia, Janumet & Janumet XR
|
Merck Sharp & Dohme Corp.: |
CDTL (PDF - 1 MB)
Medical (PDF - 4 MB)
|
Clinical pharmacology (PDF - 339 KB) |
Statistical (PDF - 623 KB) |
BOTH |
| Sildenafil - Revatio |
Pfizer, Inc. |
Medical (PDF - 6 MB) |
Clinical pharmacology (PDF -2MB) |
Statistical (PDF - 508 KB) |
BOTH |
| Sodium oxybate - Xyrem |
Jazz Pharmaceuticals
|
Medical (PDF - 193 KB) |
Clinical pharmacology (PDF - 2MB) |
Statistical (PDF - 508 KB) |
BPCA |
| Sodium picosulfate, magnesium oxide, and anhydrous citric acid - Prepopik |
Ferring Pharmaceuticals Inc. |
Medical (PDF - 193 KB) |
None |
None |
PREA |
| Sodium sulfate, potassium sulfate, and magnesium sulfate - Suprep Bowel Prep Kit |
Sponsor: Braintree Laboratories, Inc.
|
Medical (PDF - 193 KB)
|
None |
None |
PREA |
|
Sodium picosulfate, magnesium oxide and anhydrous citric acid - Clenpiq
|
Ferring Pharmaceuticals Inc.
|
CDTL (PDF - 1 MB) |
None |
None |
PREA |
| Sofpironium - Sofdra |
Botanix SB Inc. |
Uniview (PDF - 4 MB)
Medical (PDF - 133 KB)
|
None |
None |
PREA |
| Spinosad - Natroba |
ParaPRO, LLC |
Medical (PDF - 854 KB) |
Clinical pharmacology (PDF -171KB) |
None |
PREA |
| Sofosbuvir - Sovaldi |
Gilead Sciences, Inc. |
Medical and CDTL (PDF - 345 KB) |
Clinical pharmacology (PDF - 511 KB) |
None |
PREA |
| Sofosbuvir - Sovaldi |
Gilead Sciences, Inc. |
Medical (PDF - 218 KB) |
None |
None |
PREA |
| Sofosbuvir and velpatasvir - Epclusa |
Gilead Sciences, Inc. |
Medical (PDF - 218 KB) |
Clinical pharmacology (PDF - 511 KB) |
None |
PREA |
| Sofosbuvir and velpatasvir - Epclusa |
Gilead Sciences, Inc. |
Medical (PDF - 287 KB) |
Clinical pharmacology (PDF - 4 MB) |
None |
BOTH |
| Solifenacin succinate - VESIcare |
Astellas Pharma Global Development, Inc. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 933KB) |
Statistical PDF - 960 KB) |
BOTH |
| Solifenacin succinate - VESIcare |
Astellas Pharma Global Development, Inc. |
Medical (PDF - 3 MB)
CDTL (PDF - 1 MB)
|
Clinical pharmacology (PDF -2MB) |
Statistical (PDF - 960 KB) |
BOTH |
| Spinosad - Natroba |
ParaPRO LLC |
Medical (PDF - 458 KB) |
None |
None |
PREA |
| Sulfur Hexafluoride Lipid-Type A Microspheres) for Injectable Suspension - Lumason |
Bracco Diagnostics Inc. |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF -2MB) |
Statistical (PDF -792KB) |
PREA |
| Sulfur Hexafluoride Lipid-Type A Microspheres - Lumason |
Bracco Diagnostics, Inc. |
Medical (PDF - 3MB)
CDTL (PDF - 1 MB)
|
Clinical pharmacology (PDF - 1MB) |
Statistical (PDF - 859 KB) |
PREA |
| Sulfur Hexafluoride Lipid-Type A Microspheres - Lumason |
Bracco Diagnostics, Inc. |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF -843 KB) |
PREA |
Sugammadex - Bridion
|
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
Medical (PDF - 3 MB |
Clinical pharmacology (PDF - 2 MB)
|
Statistical (PDF - 2 MB) |
PREA |
| Sumatriptan/Naproxen - Treximet |
Pernix Therapeutics |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF -843 KB)
Statistical Addendum (PDF -702 KB)
|
BOTH |
| Sunitinib malate - Sutent |
C.P. Pharmaceuticals International C.V. |
CDTL (PDF - 680 KB) |
None |
None |
BPCA |
| Tacrolimus - Astagraf XL |
Astellas Pharma US, Inc.
|
Medical (PDF - 749 KB) |
None |
None |
PREA |
| Tadalafil - Cialis |
Eli Lilly and Company |
Medical (PDF - 1 MB) |
Clinical pharmacology (PDF - 1 MB) |
None |
BPCA |
| Tapentadol - Nucynta |
Collegium Pharmaceutical, Inc. |
CDTL - DD (PDF - 9 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF -700 KB) |
PREA |
| Tavaborole - Kerydin |
Anacor Pharmaceuticals, Inc. |
Multi-disciplinary review (PDF - 2.5 MB) |
None |
None |
BOTH |
| Tazarotene - Arazlo |
Bausch Health US, LLC |
Clinical (PDF - 1 MB) |
None |
None |
PREA |
| Tbo-filgrastim - Granix |
Sicor Biotech UAB c/o Teva Branded Pharmaceutical Products R&D |
CDTL (PDF - 176 KB)
Clinical (PDF - 196 KB)
|
Clinical pharmacology (PDF - 434 KB) |
None |
BOTH |
| Technetium 99m Tilmanocept - Lymphoseek |
Cardinal Health 414, LLC |
Multidisciplinary (PDF - 2 MB) |
None |
None |
PREA |
| Kit for the Preparation of Technetium Tc 99m Succimer Injection -NephroScan |
Theragnostics Inc |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Tedizolid phosphate - Sivextro |
Cubist Pharmaceuticals, LLC |
Medical (PDF - 9 MB) |
None |
None |
PREA |
| Teduglutide - GattexShire |
Shire-NPS Pharmaceuticals, Inc. |
Medical (PDF - 9 MB) |
None |
None |
PREA |
| Tenofovir alafenamide - Vemlidy |
Gilead Sciences, Inc |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 624 KB) |
PREA |
| Tenofovir disoproxil fumarate - Viread |
Gilead Sciences |
Medical (PDF - 2 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 1 MB) |
PREA |
| Tenofovir disoproxil fumarate - Viread |
Gilead Sciences |
CDTL (PDF - 873 KB) |
Clinical pharmacology (PDF - 180 KB) |
Statistical (PDF - 149 KB) |
BOTH |
| Teplizumab-mzwv -Tzield |
Provention Bio, Inc. |
CDTL (PDF - 5 MB)
Medical (PDF - 284 KB)
|
Clinical pharmacology (PDF - 6 MB) |
None |
PREA |
| Teriflunomide - Aubagio |
Sanofi |
CTDL (PDF - 3 MB)
Clinical (PDF - 3 MB)
|
Clinical pharmacology (PDF - 2 MB) |
Statistical (PDF - 410KB) |
BOTH |
| Tetracaine hydrochloride - Steri-Unit |
Alcon Research, Ltd. |
DD Medical Summary (PDF - 2 MB)
Medical (PDF - 1 MB)
|
Clinical pharmacology (PDF - 158 KB) |
Statistical (PDF - 2 MB) |
PREA |
| Tetracaine HCl and Oxymetazoline HCl - Kovanaze |
St. Renatus, LLC |
Medical (PDF - 12 MB) |
Clinical pharmacology (PDF - 11 MB) |
Statistical (PDF - 2 MB) |
PREA |
|
Tezepelumab -Tezspir
|
AstraZeneca |
Medical (PDF - 10 MB) |
None |
None |
PREA |
Ticagrelor - Brilinta
|
AstraZeneca Pharmaceuticals LP |
Medical (PDF - 10 MB) |
Clinical pharmacology (PDF - 1 MB) |
Statistical (PDF - 325 KB) |
BPCA |
Tilmanocept - Lymphoseek
|
Cardinal Health 414, LLC |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Tiotropium bromide - Spiriva Respimat |
Boehringer Ingelheim Pharmaceuticals, Inc. |
Medical (PDF -11.9MB)
Medical Addendum (PDF - 418 KB
|
Clinical pharmacology (PDF - 6 MB) |
Statistical (PDF - 1 MB)
Statistical Addendum (PDF - 327 KB)
|
PREA |
| Tiotropium bromide - Spiriva Respimat |
Boehringer Ingelheim Pharmaceuticals, Inc. |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 2MB) |
Statistical (PDF - 432K B) |
BOTH |
| Tobramycin 300 mg/4mL inhalation solution - Bethkis |
Cornerstone Therapeutics |
Medical (PDF - 5 MB) |
Clinical pharmacology (PDF - 78 KB) |
Statistical (PDF - 687 KB) |
PREA |
|
Tocilizumab - Actemra
|
Genentech, Inc. |
Medical (PDF - 72 KB)
Medical (PDF - 109 KB)
|
Clinical pharmacology (PDF - 195 KB) |
None |
PREA |
|
Tocilizumab - Actemra
|
Genentech, Inc. |
Medical (PDF - 8 MB) |
None |
None |
BOTH |
| Tocilizumab-bavi - Tofidence |
Biogen MA Inc |
Medical (PDF - 5 MB) |
None |
None |
PREA |
| Tocilizumab-aazg -Tyenne |
Fresenius Kabi USA, LLC |
CDTL (PDF - 42K B)
Medical (PDF - 8 MB)
|
None |
None |
PREA
|
| Tofacitinib - Xeljanz |
Pfizer, Inc. |
Medical (PDF - 8 MB) |
None |
None |
PREA |
| Topiramate - Topamax |
Janssen Pharmaceuticals, Inc. |
Medical (PDF - 8 MB) |
None |
Statistical (PDF - 881 KB) |
PREA |
|
Topiramate - Eprontia
|
Azurity Pharmaceuticals, Inc. |
Medical (PDF - 669 KB) |
Clinical pharmacology (PDF - 565 KB) |
None |
PREA |
| Trabectedin - Yondelis |
Janssen Products, LP |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 683 KB) |
None |
BPCA |
| Trace elements injection 4 - Tralement |
American Regent, Inc. |
Medical (PDF - 2.5 MB) |
None |
None |
PREA |
| Trace elements injection 4 - Tralement |
American Regent, Inc. |
Medical (PDF - 321 KB) |
None |
None |
PREA |
| Tralokinumab-ldrm - Adbry |
LEO Pharma A/S c/o LEO Pharma Inc |
Unireview (PDF - 4MB)
Medical (PDF - 32 KB)
|
None |
None |
PREA |
| Trametinib - Mekinist |
Novartis Pharmaceuticals Corporation
|
Medical (PDF - 18 MB) |
None |
None |
PREA |
| Trametinib - Mekinist |
Novartis Pharmaceuticals Corporation |
Medical (PDF - 800 KB) |
Clinical pharmacology (PDF - 616 KB) |
None |
BPCA |
| Tranexamic acid - Lysteda |
Ferring Pharmaceuticals, Inc. |
None |
Clinical pharmacology (PDF - 1 MB) |
None |
PREA |
| Tretinoin lotion - Altreno |
Dow Pharmaceutical Sciences, Inc. |
Medical (PDF - 3 MB) |
None |
None |
PREA |
| Tretinoin and benzoyl peroxide - Twyneo |
Sol-Gel Technologies Ltd. c/o B&H Consulting Services Inc. |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Trifarotene - Aklief |
Galderma Research and Development |
Medical (PDF - 3 MB) |
None |
None |
PREA |
| Trofinetide - Daybue |
Acadia Pharmaceuticals Inc |
Medical (PDF - 212 KB)
Medical (PDF - 6 MB)
|
Clinical pharmacology (PDF - 6 MB) |
Statistical (PDF - 2 MB)
Statistical Errata (PDF - 28 KB)
|
BPCA |
| Tropicamide and phenylephrine - MYDCOMBI |
Eyenovia, Inc. |
CDTL - DD (PDF - 6 MB) |
None |
Statistical (PDF - 2 MB) |
PREA |
| Upadacitinib - Rinvoq |
AbbVie Inc. |
Medical (PDF - 10 MB) |
None |
None |
PREA |
| Upadacitinib - Rinvoq and Rinvoq LQ |
AbbVie Inc. |
Medical (PDF - 4 MB) |
None |
None |
PREA |
| Ustekinumab - Stelara |
Janssen Biotech, Inc. |
Medical (PDF - 352 MB) |
Clinical pharmacology (PDF - 3 MB) |
None |
PREA |
| Ustekinumab - Stelara |
Janssen Biotech, Inc. |
Medical (PDF - 8 MB) |
None |
None |
PREA |
| Ustekinumab-aekn - Selarsdi |
Alvotech USA Inc. PharmaLex US Corporation |
CDTL (PDF - 123 KB)
Medical (PDF - 5 MB)
|
Clinical pharmacology (PDF - 9 KB) |
None |
PREA |
| Valganciclovir hydrochloride - Valcyte |
Roche Palo Alto LLC c/o Genentech, Inc.orporated |
Medical (PDF - 3 MB) |
Clinical pharmacology (PDF - 6 MB) |
None |
PREA |
|
Valsartan - Diovan
|
Novartis Pharmaceuticals Corporation |
Medical (PDF - 2 MB) |
None |
None |
PREA |
|
Varenicline - Chantix
|
PF Prism C V |
None |
Clinical pharmacology (PDF - 3 MB) |
None |
BOTH |
| Vilazodone hydrochloride - Viibryd |
Allergan Sales, LLC |
Medical (PDF - 3 MB) |
None |
None |
BOTH |
|
Vortioxetine - Trintellix
|
Takeda Pharmaceuticals, USA, Inc. |
Medical (PDF - 3 MB) |
None |
None |
BOTH |
| Vortioxetine - Trintellix |
Takeda Pharmaceuticals, USA, Inc. |
Medical (PDF - 3 MB) |
None |
None |
BOTH |
| Ustekinumab - Stelara |
Janssen Biotech Inc. |
CDTL (PDF - 593 KB)
Medical (PDF - 5 MB)
|
Clinical pharmacology (PDF - 3 MB) |
Statistical (PDF - 275 KB) |
PREA |
| Vigabatrin - Sabril |
Lundbeck LLC. |
Medical (PDF - 4MB) |
Clinical pharmacology (PDF - 2.3MB) |
Statistical (PDF - 698KB) |
BOTH |
Viloxazine extended release capsules - Qelbree
|
Supernus Pharmaceuticals, Inc. |
Medical (PDF - 13 KB)
Medical (PDF - 13 MB)
|
None |
None |
PREA |
| Viloxazine extended-release capsules - Qelbree |
Supernus Pharmaceuticals, Inc. |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Voriconazole - Vend |
PF PRISM C.V. |
Medical (PDF - 2 MB)
Medical PDF - 200 KB)
|
Clinical Pharmacology (PDF - 1 MB) |
Statistical (PDF - 200 KB) |
PREA |
| Xenon Xe 129 hyperpolarized - XENOVIEW |
Polarean Inc. |
Medical PDF - 200 KB) |
None |
None |
PREA |
| Zinc sulfate - None |
American Regent, Inc. |
Medical (PDF - 4 MB) |
None |
None |
PREA |
Ziprasidone - Geodon
|
Viatris Specialty LLC |
Medical (PDF - 2 MB) |
None |
None |
PREA |
| Zolmitriptan - Zomig |
AstraZeneca Pharmaceuticals LP |
Medical (PDF - 5 MB) |
None |
Statistical (PDF - 3 MB) |
PREA |
