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U.S. Department of Health and Human Services

For Consumers

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Approval of generic abacavir tablets, 300 mg

On June 18, 2012, FDA granted approval for a generic formulation of abacavir tablets, 300 mg, manufactured by Mylan Pharmaceuticals, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

FDA has determined that the generic formulation is bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, ZiagenTablets, a product of VIIV Healthcare Company.

Approval of this generic formulation means that it may be marketed in the United States.

A complete list of approved generic formulations of antiretroviral drugs used in the treatment of HIV infection is available on the FDA web site.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration