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Tentative approval of lamivudine/stavudine fixed dose combination

Food and Drug Administration - November 5, 2007
Richard Klein & Kimberly Struble

On November 2, 2007, the Food and Drug Administration (FDA) granted tentative approval for a fixed dose combination of lamivudine/stavudine (150 mg/40 mg & 150 mg/30 mg combination tablets) under expedited procedures for the President's Emergency Plan for AIDS Relief (PEPFAR) program. The product is made by Matrix Laboratories Limited, of Hyderabad, India.

Lamivudine and stavudine, are anti-viral drugs indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Combination products such as this one 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


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SOURCE: Food and Drug Administration (FDA).

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