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Tentative approval of stavudine, lamivudine and nevirapine fixed dose combination tablets
  On February 27, 2009, FDA granted tentative approval to stavudine, lamivudine and nevirapine fixed dose combination tablets,30mg/150mg/200mg & 40mg/150mg/200mg,made by Pharmacare Limited t/a Aspen Pharmacare of South Africa. The product is indicated for the treatment of HIV-1 infection. Stavudine, lamivudine and nevirapine are anti-viral drugs indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. Combination products like this one can decrease pill burden and may 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 the President?s Emergency Plan for AIDS Relief (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.
The application was reviewed under expedited review provisions for PEPFAR, A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA website.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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