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U.S. Department of Health and Human Services

For Consumers

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Tentative approval of efavirenz tablets

On March 26, 2007, FDA granted tentative approval for a generic drug formulation of efavirenz tablets (600 mg), manufactured by Strides Acrolab Ltd., Bangalore, India, under the expedited review provisions created by FDA for the President's Emergency Plan for AIDS Relief (PEPFAR).

The tentatively approved product is a generic version of the Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI), Sustiva Tablets, 600 mg, for use in combination with other antiretroviral agents in the treatment of HIV infection.  Sustiva, manufactured by Bristol Myers Squibb Co., is currently subject to patent protection.

FDA's tentative approval of this product means that although existing patents and/or exclusivities 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 PEPFAR program for use in qualifying countries.

A complete list of approved and tentatively approved antiretroviral drugs associated with PEPFAR is available 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