Tentative approval for a generic formulation of lamivudine 150 mg and 300 mg tablets

On October 7, 2008, FDA granted tentative approval for a generic formulation of lamivudine 150 mg and 300 mg tablets, manufactured by Macleods Pharmaceuticals Limited of  Daman, India, indicated for use in combination with other anti-retroviral drugs for the treatment of HIV-1 infection. 

They come packaged as follows:

• 150 mg tablets: HDPE Bottles 60's
• 150 mg tablets, blisters: 6x10's
• 300 mg tablets: HDPE Bottles 30's

"Tentative approval" means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase outside the United States under the President’s Emergency Plan for AIDS Relief (PEPFAR) . This product is a generic version of Epivir, manufactured by GlaxoSmithKline, which is still under patent protection.

Effective patent dates can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book."

This application was reviewed under expedited review provisions developed by FDA for 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 list of all 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