Tentative approval of generic atazanavir sulfate capsules, 300 mg

On August 19, 2010, FDA granted tentative approval for generic atazanavir sulfate capsules, 300 mg, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. This generic formulation, manufactured by Emcure Pharmaceuticals Ltd. of Pune, India, was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR).

FDA's tentative approval means that although a product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents prevent marketing of the product in the United States. Tentative approval, however, does qualify the product for consideration for purchase under the President's Emergency Plan for AIDS Relief, or PEPFAR program.

This tentative approval is a generic formulation of Reyataz Capsules, 300 mg of Bristol Myers Squibb. Effective patent dates for this and all approved drugs can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"

As with all generic applications, FDA conducts an on-site inspection of the manufacturing facilities and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA web site.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration