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Generic 3TC Gets FDA Approval
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FDA granted tentative approval on March 19, 2007 for a generic formulation of lamivudine tablets (150 mg), manufactured by Matrix Laboratories, Inc., of Hyderabad, India, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief (PEPFAR). Final approval cannot be granted at this time because the reference drug product, Epivir Tablets, a product of GlaxoSmithKline, is currently subject to patent protection.
Lamivudine is indicated for use in combination with other antiretroviral agents for the treatment of HIV infection.
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 PEPFAR program for use in PEPFAR listed countries.
A complete list of approved and tentatively approved antiretroviral drugs associated with PEPFAR is available at http://www.fda.gov/oia/pepfar.htm.
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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