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For Consumers

Tentative approval of abacavir sulfate and lamivudine tablets 60mg/30mg for pediatric patients

On January 31, 2012, the Food and Drug Administration granted tentative approval for abacavir sulfate and lamivudine tablets, 60 mg/30 mg under the expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR).

The formulation, manufactured by Mylan Pharmaceuticals of Hyderabad, India, is indicated for use in combination with other antiretrovirals for the treatment of HIV-1 infection in pediatric patients 3 months and older weighing at least 5 kg.

"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

Page Last Updated: 08/21/2014
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