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On February 3, 2014, FDA granted approval for a generic fixed dose combination formulation of lamivudine and zidovudine tablets USP, 150 mg/300 mg, manufactured by Hetero Labs 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.
A complete list of approved generic formulations of antiretroviral drugs used in the treatment of HIV infection is available on the FDA web site.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
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