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On November 29, 2010, the Food and Drug Administration granted tentative approval for a formulation of abacavir sulfate tablets, 60 mg, made by Matrix Laboratories Limited of Hyberdad, India, indicated for use in combination with other antiretrovirals for the treatment of HIV-1 infection. The tablet formulation is intended for pediatric use, allowing dosing for patients weighing as little as 5kg, and is unique in that it can be dispersed in liquid for patients unable to swallow tablets.
FDA's tentative approval means that although a product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents and/or proprietary issues currently prevent marketing of the product in the United States. Tentative approval, however, does qualify the product for consideration for purchase under the President's Emergency Plan for AIDS Relief, or PEPFAR program.
As with all applications, FDA conducts an on-site inspection of the manufacturing facilities and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval 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 can be found on the FDA web site.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
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