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On September 29, 2010, the Food and Drug Administration (FDA) granted tentative approval for a generic formulation of abacavir sulfate tablets, 300 mg, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
This generic formulation is manufactured by Hetero Drugs Limited, of Hyberdad, India. The application was reviewed under expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR).
Tentative approval means that FDA has concluded that a drug product has met all of the required quality, safety and efficacy standards, even though it may not yet be marketed in the U.S. due to existing patents and/or exclusivity. It does, however, make the product eligible for purchase and use under the PEPFAR program outside the United States.
Current patent information about approved drugs can be found in FDA's 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.
You can find a complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan on the FDA web site.
This formulation of abacavir sulfate, a Nucleoside Reverse Transcriptase Inhibitors (NRTI) is a generic version of Ziagen Tablets, 300 mg, a product of VIIV Healthcare Co..
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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