Food and Drug Administration - September 14, 2008
Richard Klein & Kimberly Struble

On September 12, 2008, FDA granted tentative approval for abacavir sulfate 60 mg scored tablet for use in pediatric patients. Abacavir sulfate 60 mg scored tablets are manufactured by Aurobindo Pharma Limited, Hyberdad, India. Abacavir sulfate is an antiviral agent in the Nucleoside Reverse Transcriptase Inhibitor (NRTI) class.

"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). The application was reviewed under expedited review provisions developed 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

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SOURCE: Food and Drug Administration (FDA).

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