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U.S. Department of Health and Human Services

For Consumers

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Tentative approval of atazanavir sulfate capsules, 100 mg, 150 mg, 200 mg, and 300 mg

On January 31,2014, FDA granted tenative approval for a generic formulation of atazanavir sulfate capsules, 100 mg, 150 mg, 200 mg, and 300 mg, indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection.

The product is made by Aurobindo Pharma Ltd of Hyderabad, India.  It is a generic version of Reyataz capsules, made by Bristol -Myers-Squibb Company.

The application was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR).

"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.

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