October 6, 2010 (FinancialWire) (Go to http://www.financialwire.net/?s=ftrdnwswnd for all of today’s featured news.) — Mylan, Inc. (NASDAQ: MYL) said that its subsidiary Matrix Laboratories Ltd.,  has received tentative approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief (PEPFAR) for its abbreviated new drug application for Atazanavir Sulfate Capsules, 150 mg and 300 mg.

Mylan said that the product will be eligible for purchase outside the U.S. in certain developing countries.

Atazanavir Sulfate Capsules are the generic version of Bristol Myers Squibb's Reyataz Capsules. It is used in combination with other medications to control HIV infection and is included in the ARV class of drugs known as HIV protease inhibitors. Unlike currently available protease inhibitors, Atazanavir offers once-daily dosing, a distinctive resistance profile and may result in fewer metabolic complications. Until now, a generic version of this product has not been made widely available in developing countries.

According to Mylan president Heather Bresch, “Atazanavir has a distinct resistance profile compared with other protease inhibitors and is an important addition to the product portfolio being made available to patients in developing countries.”

The FDA's tentative approval under PEPFAR means that Matrix's product meets all of the agency's manufacturing quality, safety and efficacy standards.

Matrix's range of ARV products includes active pharmaceutical ingredients and first- and second-line finished doses.

Pennsylvania-based Mylan is a generic and specialty pharmaceutical firm with customers in more than 140 countries and territories.

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