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Approval of generic formulation of lamivudine and zidovudine Tablets, 150 mg/300 mg


On May 15, 2012, FDA granted approval for a generic formulation fixed dose combination of of two antiretroviral medicines, lamivudine and zidovudine tablets, 150 mg/300 mg, (nucleoside reverse transcriptase inhibitors, or NRTIs)  indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The tablets are manufactured by Lupin Limited, headquartered in Mumbai, India.

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


Copyright © 2012 -FDA News, Publisher. All rights reserved to Food and Drug (FDA) Administration FDA.

Information in this article was accurate in May 24, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.