2023 First Generic Drug Approvals
90
208237
Memantine and Donepezil Hydrochloride Extended-Release Capsules, 21 mg/10 mg and 28 mg/10 mg
ANI Pharmaceuticals, Inc.
Namzaric (Memantine and Donepezil Hydrochloride) Extended-Release Capsules
12/15/2023
For the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily
89
208070
Dabigatran Etexilate Capsules, 75 mg, 110 mg, 150 mg
Apotex, Inc.
Pradaxa (Dabigatran Etexilate) Capsules
12/15/2023
To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; for the treatment and prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE); for the prophylaxis of DVT and PE in certain patients; for the treatment of and to reduce the recurrance of venous thromboembolic events
88
217987
Vasopressin in 5% Dextrose Injection, 20 units/100 mL (0.2 units/mL) Single-Dose Vials
Cipla Limited
Vasostrict (Vasopressin) Injection
12/6/2023
To increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines
87
215636
Methylene Blue Injection USP, 10 mg/2 mL (5 mg/mL) and 50 mg/10 mL (5 mg/mL) Single-Dose Vials
Zydus Worldwide DMCC
ProvayBlue (Methylene Blue) Injection
12/5/2023
For the treatment of pediatric and adult patients with acquired methemoglobinemia
86
206027
Bromfenac Ophthalmic Solution, 0.07%
Lupin Limited
Prolensa (Bromfenac) Ophthalmic Solution
11/22/2023
For the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery
85
211097
Teriparatide Injection USP, 600 mcg/2.4 mL (250 mcg/mL) Single-Patient-Use Prefilled Pens
Apotex Inc.
Forteo (Teriparatide) Injection
11/16/2023
For the rreatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy; increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy; treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy
84
208569
Teriparatide Injection USP, 600 mcg/2.4 mL (250 mcg/mL) Single-Patient-Use Prefilled Pens
Teva Pharmaceuticals USA, Inc.
Forteo (Teriparatide) Injection
11/16/2023
For the rreatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy; increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy; treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy
83
213516
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid
Jubilant DraxImage Inc
Technetium TC 99M sulfur colloid kit
11/9/2023
Diagnostic radiopharmaceutical to assist in the localization of lymph nodes draining a primary tumor in adult patients with breast cancer; for evaluation of peritoneo-venous (LeVeen) shunt patency in adults; imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow; studies of esophageal transit and gastroesophageal reflux; detection of pulmonary aspiration of gastric contents
82
217713
Pazopanib Tablets, 200 mg
Apotex Inc
Votrient (Pazopanib) Tablets
10/19/2023
For the treatment of adults with: advanced renal cell carcinoma; advanced soft tissue sarcoma who have received prior chemotherapy
81
217517
Pazopanib Tablets, 200 mg
Teva Pharmaceuticals, Inc.
Votrient (Pazopanib) Tablets
10/19/2023
For the treatment of adults with: advanced renal cell carcinoma; advanced soft tissue sarcoma who have received prior chemotherapy
80
215837
Pazopanib Tablets, 200 mg
Sun Pharmaceutical Industries Limited
Votrient (Pazopanib) Tablets
10/19/2023
For the treatment of adults with: advanced renal cell carcinoma; advanced soft tissue sarcoma who have received prior chemotherapy
79
217155
Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL)
Amneal EU, Limited
Tranexamic Acid
10/16/2023
Antifibrinolytic indicated in patients with hemophilia for shortterm use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction
78
217134
Iopamidol Injection USP, 41% Single-Dose Vial
Hainan Poly Pharm. Co., Ltd.
Isovue-200 (Iopamidol) Injection
9/27/2023
For angiography throughout the cardiovascular system; coronary arteriography and ventriculography; pediatric angiocardiography; selective visceral arteriography and aortography; peripheral venography; adult and pediatric intravenous excretory urography; intravenous adult and pediatric contrast enhancement of computed tomographic head and body imaging
77
216878
Tofacitinib Oral Solution, 1 mg/mL
Slayback Pharma LLC
Xeljanz (Tofacitinib) Oral Solution
9/25/2023
For the treatment of Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Ulcerative Colitis; Polyarticular Course Juvenile Idiopathic Arthritis
76
215709
Fluorescein Injection USP, 500 mg/5 mL (100 mg/mL) and 500 mg/2 mL (250 mg/mL) Single-Dose Vials
Nexus Pharmaceuticals Inc.
AK-FLUOR (Fluorescein) Injection
9/25/2023
Indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature
75
216081
Gadobutrol Injection, 30 mmol/30 mL (1 mmol/mL) and 65 mmol/65 mL (1 mmol/mL) Imaging Bulk Package
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Gadavist (Gadobutro) Injection
9/8/2023
For use with magnetic resonance imaging to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system; to assess the presence and extent of malignant breast disease; to evaluate known or suspected supra-aortic or renal artery disease; to assess myocardial perfusion (stress, rest) and late gadolinium enhancement
74
217174
Calcium Gluconate Injection, 1000 mg/50 mL and 2000 mg/100 mL (20 mg/mL) Single-Dose Containers
Amneal EU, Limited
Calcium Gluconate Injection
9/5/2023
For the treatment of acute symptomatic hypocalcemia
73
215572
Spironolactone Oral Suspension, 25 mg/5 mL
Amneal Pharmaceuticals LLC
Carospir (Spironolactone) Oral Suspension
9/5/2023
For the treatment of NYHA Class III-IV heart failure and reduced ejection fraction ; to use as an add-on therapy for the treatment of hypertension, to lower blood pressure; for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions
72
215570
Palbociclib Tablets, 75 mg, 100 mg, and 125 mg
Synthon Pharmaceuticals, Inc.
Ibrance (Palbociclib) Tablets
8/28/2023
For the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy, or fulvestrant in patients with disease progression following endocrine therapy
71
217442
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
Ascent Pharmaceuticals, Inc
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
70
217194
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
Alkem Laboratories Limited
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
69
217068
Lisdexamfetamine Dimesylate Chewable Tablets, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg
Ascent Pharmaceuticals Inc
Vyvanse (Lisdexamfetamine Dimesylate ) Chewable Tablets
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
68
216944
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
Apotex Inc
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
67
216266
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
Prinston Pharmaceutical Inc.
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
66
215802
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
Lannett Company, Inc.
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
65
215415
Lisdexamfetamine Dimesylate Chewable Tablets, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg
Teva Pharmaceuticals USA, Inc.
Vyvanse (Lisdexamfetamine Dimesylate ) Chewable Tablets
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
64
215330
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
Rhodes Pharmaceuticals L.P.
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
63
214547
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
Norwich Pharmaceuticals, Inc.
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
62
214484
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
Sun Pharmaceutical Industries, Inc.
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
61
214134
Lisdexamfetamine Dimesylate Chewable Tablets, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg
Sun Pharmaceutical Industries, Inc.
Vyvanse (Lisdexamfetamine Dimesylate ) Chewable Tablets
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
60
211840
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
SpecGx LLC
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
59
202835
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
Mylan Pharmaceuticals Inc.
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
58
202830
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
Amneal Pharmaceuticals LLC
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
57
202827
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
Hikma Pharmaceuticals USA Inc.
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
56
202802
Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg
Actavis Elizabeth LLC
Vyvanse (Lisdexamfetamine Dimesylate ) Capsules
8/25/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older; moderate to severe binge eating disorder (BED) in adults
55
215609
Tretinoin Gel (Microsphere), 0.08%
Encube Ethicals Private Limited
Retin-A-Micro (Tretinoin) Gel Microsphere
8/22/2023
For the topical treatment of acne vulgaris
54
216541
Calcium Gluconate Injection 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package
B. Braun Medical, Inc.
Calcium Gluconate in Sodium Chloride Injection
8/21/2023
For the treatment of acute symptomatic hypocalcemia
53
214640
Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 0.1 mg/0.02 mg and 75 mg
Xiromed Pharma Espana, S.L.
Balcoltra (Levonorgestrel and Ethinyl Estradiol and Ferrous Bisglycinate) Tablets
8/16/2023
For use by females of reproductive potential to prevent pregnancy
52
215266
Halobetasol Propionate Topical Foam, 0.05%
Padagis Israel Pharmaceuticals Ltd.
Lexette (Halobetasol Propionate) Topical Foam
8/11/2023
For the topical treatment of plaque psoriasis in patients twelve (12) years of age and older
51
215081
Lifitegrast Ophthalmic Solution, 5%
Micro Labs Limited
Xiidra (Lifitegrast) Ophthalmic Solution
8/4/2023
For the treatment of the signs and symptoms of dry eye disease
50
206081
Saxagliptin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, 2.5 mg/1,000 mg, and 5 mg/1,000 mg
Sun Pharmaceutical Industries Limited
Kombiglyze XR (Saxagliptin and Metformin Hydrochloride) Extended-Release Tablets
7/31/2023
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate
49
206078
Saxagliptin Tablets, 2.5 mg and 5 mg
Sun Pharmaceutical Industries Limited
Onglyza (Saxagliptin) Tablets
7/31/2023
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
48
205994
Saxagliptin Tablets, 2.5 mg and 5 mg
Glenmark Pharmaceuticals Limited
Onglyza (Saxagliptin) Tablets
7/31/2023
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
47
205981
Saxagliptin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/500 mg, 2.5 mg/1,000 mg, and 5 mg/1,000 mg
Mylan Pharmaceuticals Inc.
Kombiglyze XR (Saxagliptin and Metformin Hydrochloride) Extended-Release Tablets
7/31/2023
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate
46
205980
Saxagliptin Tablets, 2.5 mg and 5 mg
Mylan Pharmaceuticals Inc.
Onglyza (Saxagliptin) Tablets
7/31/2023
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
45
205972
Saxagliptin Tablets, 2.5 mg and 5 mg
Aurobindo Pharma Limited
Onglyza (Saxagliptin) Tablets
7/31/2023
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
44
205941
Saxagliptin Tablets, 2.5 mg and 5 mg
Amneal Pharmaceuticals of NY, LLC
Onglyza (Saxagliptin) Tablets
7/31/2023
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
43
208980
Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
Zydus Pharmaceuticals (USA) Inc.
Mozobil (Plerixafor) Injection
7/24/2023
In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma
42
215698
Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
Kindos Pharmaceuticals Co., Ltd.
Mozobil (Plerixafor) Injection
7/24/2023
In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma
41
215334
Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
Amneal EU, Limited
Mozobil (Plerixafor) Injection
7/24/2023
In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma
40
213672
Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
Eugia Pharma Specialities Limited
Mozobil (Plerixafor) Injection
7/24/2023
In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma
39
211901
Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
MSN Laboratories Private Limited
Mozobil (Plerixafor) Injection
7/24/2023
In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma
38
205197
Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
Teva Pharmaceuticals USA, Inc.
Mozobil (Plerixafor) Injection
7/24/2023
In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma
37
205182
Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) Single-Dose Vial
Dr. Reddy's Laboratories Limited
Mozobil (Plerixafor) Injection
7/24/2023
In combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma
36
215893
Ponatinib Tablets, 15 mg and 45 mg
Apotex Inc.
Iclusig (Ponatinib) Tablets
7/14/2023
For the treatment of adult patients with Chronic phase chronic myeloid leukemia (CML); accelerated phase or blast phase CML or Philadelphia chromosome positive acute lymphoblastic leukemia ; T315I-positive CML or T315I-positive Ph+ ALL
35
216947
Ertugliflozin Tablets, 5 mg and 15 mg
Aurobindo Pharma Limited
Steglatro (Ertugliflozin) Tablets
7/13/2023
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
34
213369
Oxcarbazepine Extended-Release Tablets, 150 mg, 300 mg, and 600 mg
Apotex Inc.
Oxtellar XR (Oxcarbazepine) Extended-Release Tablets
7/13/2023
For the treatment of partial-onset seizures in patients 6 years of age and older
33
213195
Naltrexone for Extended-Release Injectable Suspension, 380 mg/vial, Single-Dose Vial
Teva Pharmaceuticals USA, Inc.
Vivitrol (Naltrexone) for Extended-Release Injectable Suspension
7/6/2023
For the prevention of relapse to opioid dependence, following opioid detoxification
32
210659
Alcaftadine Ophthalmic Solution, 0.25% (OTC)
Eugia Pharma Specialities Limited
Lastacaft (Alcaftadine) Ophthalmic Solution
6/23/2023
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
31
209253
Amphetamine Extended-Release Orally Disintegrating Tablets, 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg and 18.8 mg
Actavis Laboratories FL, Inc.
Adzenys XR-ODT (Amphetamine) Extended-Release Orally Disintegrating Tablets
6/22/2023
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older
30
211287
Tiotropium Bromide Inhalation Powder, 18 mcg/capsule
Lupin Inc
Spiriva HandiHaler (Tiotropium Bromide) Inhalation Powder
6/20/2023
For the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
29
215902
Safinamide Tablets, 50 mg and 100 mg
Aurobindo Pharma Limited
Xadago (Safinamide) Tablets
6/14/2023
Adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes
28
215035
Amlodipine Benzoate Oral Suspension, 1 mg/mL (150 mL)
Amneal Pharmaceuticals LLC
Katerzia (Amlodipine Benzoate) Oral Suspension
6/13/2023
For the treatment of hypertension and coronary artery disease
27
214008
Trifluridine and Tipiracil Tablets, 15 mg/6.14 mg and 20 mg/8.19 mg
Natco Pharma Limited
Lonsurf (Trifluridine and Tipiracil) Tablets
6/13/2023
For the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy
26
214337
Sugammadex Injection, 200 mg/2 mL (100 mg/mL), 500 mg/5 mL (100 mg/mL) Single-Dose Vial
Aspiro Pharma Limited
Bridion (Sugammadex) Injection
6/9/2023
Reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery
25
217252
Baclofen Oral Suspension, 25 mg/5 mL (5 mg/mL)
Slayback Pharma LLC
Fleqsuvy (Baclofen) Oral Suspension
6/8/2023
Treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity and some value in patients with spinal cord injuries and other spinal cord diseases
24
215017
Obeticholic Acid Tablets, 5 mg and 10 mg
MSN Laboratories Private Limited
Ocaliva (Obeticholic Acid ) Tablets
5/30/2023
For the treatment of adult patients with primary biliary cholangitis
23
214980
Obeticholic Acid Tablets, 5 mg and 10 mg
Lupin Limited
Ocaliva (Obeticholic Acid ) Tablets
5/30/2023
For the treatment of adult patients with primary biliary cholangitis
22
214862
Obeticholic Acid Tablets, 5 mg and 10 mg
Apotex Inc.
Ocaliva (Obeticholic Acid ) Tablets
5/30/2023
For the treatment of adult patients with primary biliary cholangitis
21
091076
Diazepam Rectal Gel Rectal Delivery System, 10 mg and 20 mg
Novel Laboratories, Inc.
Diastat AcuDial (Diazepam) Rectal Gel Rectal Delivery System
5/30/2023
For the management of selected, refractory, patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity
20
216435
Edetate Calcium Disodium Injection, USP, 1,000 mg/5 mL (200 mg/mL) Single-Dose Vial
Casper Pharma LLC
Calcium Disodium Versenate Injection
5/3/2023
For the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults
19
217213
Methsuximide Capsules USP, 300 mg
Novitium Pharma LLC
Celontin (Methsuximide) Capsules
5/1/2023
For the control of absence (petit mal) seizures that are refractory to other drugs
18
213267
Thalidomide Capsules USP, 50 mg, 100 mg, 150 mg, 200 mg
Natco Pharma Limited
Thalomid (Thalidomide) Capsules
4/27/2023
For the treatment of patients with newly diagnosed multiple myeloma; for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL); as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence
17
216159
Midazolam in 0.9% Sodium Chloride Injection, 50 mg/50 mL (1mg/mL) and 100 mg/100 mL (1 mg/mL) Single-Dose Bags
Hikma Pharmaceuticals USA Inc.
Midazolam in 0.9% Sodium Chloride Injection
4/17/2023
Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting
16
204379
Estradiol Transdermal System USP, 0.014 mg/day
Zydus Noveltech, Inc
Menostar (Estradiol) Transdermal System
4/17/2023
For the prevention of postmenopausal osteoporosis
15
215933
Loteprednol Etabonate Ophthalmic Suspension, 0.2%
Akorn Operating Company LLC
Alrex (Loteprednol Etabonate) Ophthalmic Suspension
4/12/2023
For the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis
14
215328
Budesonide Rectal Foam, 2 mg/dose
Padagis Israel Pharmaceuticals Ltd.
Uceris (Budesonide) Rectal Foam
4/12/2023
For the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge
13
214226
Tenofovir Alafenamide Tablets, 25 mg
Lupin Limited
Vemlidy (Tenofovir Alafenamide) Tablets
3/30/203
For the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease
12
214688
Calcipotriene and Betamethasone Dipropionate Foam, 0.005%/0.064%
Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Limited
Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam
3/21/2023
For the topical treatment of plaque psoriasis in patients 12 years and older
11
209738
Tofacitinib Tablets, 5 mg and 10 mg
Micro Labs Limited
Xeljanz (Tofacitinib) Tablets
3/13/2023
For the treatment of adult patients with moderately to severely active rheumatoid arthritis; active psoriatic arthritis; moderately to severely active ulcerative colitis
10
205770
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules, 140 mg/125 mg/125 mg
Par Pharmaceutical, Inc.
Pylera (Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride) Capsules
3/6/2023
For the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori
9
214836
Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC)
L. Perrigo Company
Advil Dual Action with Acetaminophen (Acetaminophen and Ibuprofen) Tablets (OTC)
2/28/2023
Temporarily relieves minor aches and pains due to headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis
8
217219
Tiopronin Delayed-Release Tablets, 100 mg and 300 mg
Par Pharmaceutical, Inc.
Thiola (Tiopronin) EC Tablets
2/24/2023
For the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone
7
215408
Doxepin Hydrochloride Cream, 5%
Teva Pharmaceuticals Development, Inc.
Zonalon (Doxepin Hydrochloride) Cream
2/17/2023
For the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus
6
216167
Topiramate Extended-Release Capsules, 200 mg
Zydus Pharmaceuticals (USA) Inc.
Trokendi XR (Topiramate) Extended-Release Capsules
2/9/2023
Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older; adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older; preventive treatment of migraine in patients 12 years of age and older
5
213947
Tirofiban Hydrochloride Injection, 5 mg/100 mL (50 mcg/mL), Single-Dose Containers
Nexus Pharmaceuticals, Inc.
Aggrastat (Tirofiban Hydrochloride) Injection
2/7/2023
To reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome
4
213073
Cysteine Hydrochloride Injection USP, 725 mg/10 mL (72.5 mg/mL)
Nivagen Pharmaceuticals, Inc.
Cysteine Hydrochloride Injection
1/26/2023
For use as an additive to amino acids solutions to meet nutritional requirements of newborn infants requiring total parenteral nutrition (TPN) and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN
3
211452
Morphine Sulfate Injection USP, 2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, 15 mg/mL
Hikma Pharmaceuticals International Limited
Morphine Sulfate Injection
1/12/2023
For the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
2
216496
Phenylephrine Hydrochloride Ophthalmic Solution USP, 10 %
Mankind Pharma Limited
Phenylephrine Hydrochloride Ophthalmic Solution
1/11/2023
For the purpose of dilating the pupils
1
215908
Nitisinone Capsules, 2 mg, 5 mg, 10 mg, and 20 mg
Torrent Pharma Inc.
Orfadin (Nitisinone) Capsules
1/9/2023
For the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
