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U.S. Department of Health and Human Services

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Tentative approval Efavirenz Capsules USP, 50 mg, and 200 mg for PEPFAR

On January 19, 2012, FDA granted tentative approval for efavirenz Capsules USP, 50 mg, and 200 mg, reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR).

Efavirenz is a non-nucleoside reverse transcriptase inhibitor, indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection. The product subject to this tentative approval is manufactured by Micro Labs, Bangalore, India, and is a generic version of Sustiva Capsules, 50 mg and 200 mg, a product of Bristol-Myers Squibb Co.

"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. Tentative approval does, however, make the product eligible for purchase outside the United States under the PEPFAR program.

Patent information for approved drugs is available in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book.

A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA web site.

 

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration