Tentative approval of abacavir sulfate and lamivudine fixed-dose combination

On December 19, 2008, FDA granted tentative approval for fixed-dose combination scored tablets, made by Aurobindo Pharma Limited' of Hyberdad, India, containing abacavir sulfate and lamivudine, 60mg/30mg, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection, . The tablets are dispersable in water, intended for pediatric patients 3 months - 16 years of age.

Abacavir sulfate and lamivudine are members of the Nucleoside Reverse Transcriptase Inhibitor (NRTI) class of anti-viral drugs. Fixed-dose combination products such as this one can help facilitate shipment, storage, and multi-drug treatment for HIV infected individuals.

FDA's tentative approval of this product means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product has been shown to meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and thus qualifies for consideration for purchase under the President's Emergency Program for AIDS Relief, or PEPFAR. 

FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

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