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HIV/AIDS News

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)
URL: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm256815.htm

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 http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118944.htm1

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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