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For Consumers

Tentative approval of lamivudine tablets, 150 mg and 300 mg

On June 22, 2009, FDA granted tentative approval for lamivudine tablets, 150 mg and 300 mg, manufactured by Matrix Laboratories Ltd of Hyberdad, India, for use in combination with other antiretrovirals in 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).

FDA originally granted tentative approval for the Matrix Laboratories formulation of lamivudine 150 mg on March 19, 2007.  The current tentative approval adds lamivudine tablets 300 mg, and also addresses scoring issues associated with the 150 mg tablet. 

 "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 applied to Epivir Tablets, 150 mg and 300 mg, made by GlaxoSmithKline,. Tentative approval does, however, make the product eligible for consideration for purchase outside the United States under the PEPFAR program.

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
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/20/2014
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