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For Consumers

Tentative approval of new fixed dose combination: lamivudine/stavudine

On January 20, 2007, the Food and Drug Administration (FDA) granted tentative approval for a new fixed drug combination of lamivudine/stavudine (150mg/ 30mg or 150mg/40mg) tablets manufactured by Cipla Limited, of Mumbai, India. This product was reviewed under expedited procedures for the President's Emergency Plan for AIDS Relief (PEPFAR) program.

Lamivudine and stavudine, are anti-viral drugs for the treatment of HIV-1 infection. This product represents a new combination which can decrease pill burden and could result in improved compliance for HIV infected individuals.

FDA's tentative approval of this product means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product has been shown to meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and thus qualifies for consideration for purchase under PEPFAR.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/06/2014
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