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HIV/AIDS Update – Tentative approval of lamivudine Tablets, 150 m

On March 16, 2009, the Food and Drug Administration granted tentative approval to a generic formulation of lamivudine tablets, 150 mg, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.  The drug is manufactured by Alkem Labs Ltd., of Mumbai, India.

“Tentative approval” means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not eligible for final approval, and thus cannot be marketed in the U.S., because of existing patent protections for the approved product, Epivir Tablets, 150 mg, made by GlaxoSmithKline.   However, tentative approval does make the product eligible for purchase outside the United States under the President’s Emergency Plan for AIDS Relief (PEPFAR).

The application was reviewed under expedited review provisions for PEPFAR.

Effective patent dates for 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 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.

A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President’s Emergency Plan is available on the FDA website.

Richard Klein
of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


March 17, 2009 - Posted by | 1

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