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Tentative approval of generic atazanavir sulfate capsules

Food and Drug Administration - February 8, 2008
Richard Klein & Kimberly Struble

On February 4, 2008, FDA granted tentative approval for a generic formulation of atazanavir sulfate capsules, 100 mg, 150 mg, and 200 mg, manufactured by Emcure Pharmaceuticals of Pune, India. The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR).

Indicated for the treatment of HIV infection in combination with other antiviral medications, atazanavir is a member of the protease inhibitor class of antiretroviral drugs.

As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product, and to assess the quality of the bioequivalence data supporting the application.

While tentatively approved generic products meet FDA-required standards, they cannot yet be fully approved for sale in the U.S. because of existing patent protections. However, tentative approval does make the product eligible for purchase under the PEPFAR program for treatment use in nations where PEPFAR is active.

This product is a generic formulation of Reyataz Capsules, 100 mg, 150 mg, and 200 mg, made by Bristol Myers Squibb Co. which remains subject to existing patents as listed in the agency's publication titled "Approved Drug Products with Therapeutic Equivalence Evaluations," also known as the "Orange Book."

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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