Tentative approval of abacavir sulfate and lamivudine fixed-dose combination tablet for pediatric dosing

On May 12, 2011, FDA granted tentative approval for a fixed-dose combination scored tablet containing abacavir sulfate and lamivudine, 60 mg/30 mg, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in pediatric patients 3 months and older weighing at least 5 kg. The tablets are manufactured by Cipla Limited of Mumbai, India.

The application was reviewed under the expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR).

Tentative approval means that FDA has concluded that a drug product has met all of the required quality, safety and efficacy standards, but that it may not be marketed in the U.S. due to existing patents rights. However, tentative approval makes the product eligible to be considered for purchase under the PEPFAR program.

A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan can be found 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