FDA - HIV-1 infection in adults

On August 6, 2009, FDA granted tentative approval for a generic formulation of lamivudine tablets, 150 mg and 300 mg, manufactured by Strides Arcolab Limited of Bangalore, India, indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The application was reviewed under expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR).

"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. Tentative approval does, however, make the product eligible for consideration for purchase outside the United States under the PEPFAR program.

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

This product is a generic formulation of Epivir tablets, 150 mg and 300 mg, a Nucleoside Reverse Transcriptase Inhibitor (NRTI) manufactured by GlaxoSmithKline. Patent and exclusivity Information about this product is available in the FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

You can find a complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan on the FDA web site.
http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration