Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

For Consumers

New 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

Page Last Updated: 08/21/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.