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For Consumers

Tentative approval of abacavir sulfate and lamivudine tablets, 600 mg/300 mg

On September 3, 2008, FDA granted tentative approval for the first generic combination formulation of abacavir sulfate and lamivudine tablets, 600 mg/300 mg, manufactured by Aurobindo Pharma Limited, Hyberdad, India. Abacavir sulfate and lamivudine are antivral agents in the Nucleoside Reverse Transcriptase Inhibitor (NRTI) class.  Combining two therapeutic agents in a single pill facilitates dosing, storage and distribution, and may contribute to improved patient adherence to drug regimens.

"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

This tentative approval is a generic version of Epzicom Tablets, 600 mg/300 mg, a product of SmithKline Beecham Corporation. Epzicom is subject to existing patent protection. Effective patent dates can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"

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 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

Page Last Updated: 08/12/2014
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