Two tentative approvals of lamivudine for PEPFAR

On May 29, 2012, FDA granted tentative approval for a generic formulation of lamivudine oral solution, 10 mg/mL.  The product, manufactured by Hetero Labs Limited of Hyderabad, India, is a generic version of Epivir Oral Solution, 10 mg/mL, a product of ViiV Healthcare Company.

On May 30, 2012, FDA granted tentative approval for lamivudine tablets, 150 mg and 300 mg, made by Micro Labs Limited of Goa, India, a generic formulation of Epivir Tablets, 150 mg and 300 mg, of VIIV Healthcare Company.

Both were reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief, or PEPFAR

Lamivudine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

"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 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.

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 Products
Food and Drug Administration