Food and Drug Administration - June 20, 2008
Richard Klein & Kimberly Struble

On June 19, 2008, FDA granted tentative approval to fixed dose combination lamivudine/stavudine tablets, 30mg/6mg & 60mg/12mg for oral suspension for pediatric use, manufactured by Cipla Limited of Mumbai, India. The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR),

Lamivudine and stavudine are anti-viral drugs indicated for use 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 dosing 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.

As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

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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