Press Release

Approval of Generic Formulation of Lamivudine and Zidovudine Tablets, 150 mg/300 mg

From U.S. Food and Drug Administration

May 25, 2011

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 www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ ucm118944.htm.

FDA Approval of Generic ARVs: Nevirapine and Combivir Now Off-Patent in the U.S.

Indian Pharmaceutical Company Receives Tentative Drug Approval Under PEPFAR

This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.

More on HIV Medications

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