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U.S. Department of Health and Human Services

For Consumers

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Generic approval of lamivudine and zidovudine tablets USP, 150 mg/300 mg

On May 15, 2012, FDA granted approval for a generic formulation of lamivudine and zidovudine tablets, 150 mg/300 mg, manufactured by Aurobindo Pharma Limited of Hyderabad, India, 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, Combivir Tablets, a product of GlaxoSmithKline.

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

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration