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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, Ziagen tablets, 300 mg, a product of VIIV Healthcare Company.
Approval of this generic formulation means that it may be marketed in the United States.
Generic drugs are important options that allow greater access to health care for all Americans. They are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
You can find a list of all approved generic formulations of antiretroviral drugs used in the treatment of HIV infection 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
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