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Approval of generic formulation of lamivudine and zidovudine tablets, 150 mg/300 mg - May 25, 2011

Date: May 25, 2011
Source: Food and Drug Administration (FDA)

On May 25, 2011, FDA granted approval for a generic formulation fixed dose combination of lamivudine and zidovudine tablets, 150 mg/300 mg, a two nucleoside analogue reverse transcriptase inhibitors, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The tablets are manufactured by TEVA Pharmaceuticals USA.

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

Approval of this generic formulation means that it may be marketed in the United States. A list of approved generic formulations of antiretroviral drugs used in the treatment of HIV infection can be found at

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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