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U.S. Department of Health and Human Services

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Tentative approval of copackaged antiviral regimen - lamivudine/zidovudine fixed dose combination tablets and efavirenz tablets

The Food and Drug Administration (FDA) on March 6, 2006, granted tentative approval for a copackaged antiretroviral drug regimen, consisting of lamivudine/zidovudine fixed dose combination tablets and efavirenz tablets, for the treatment of HIV-1 infection in adults. It is manufactured by Aurobindo Pharma Ltd., Hyderabad, India. There is no predicate version of this co-packaged product approved in the United States.

FDA granted tentative approval for the generic formulation of efavirenz on June 24, 2005, and for the combination of lamivudine and zidovudine on July 7, 2005, both manufactured by Aurobindo Pharma LTD. Aurobindo Pharma's lamivudine/zidovudine fixed dose combination tablets are a version of the already FDA approved Combivir tablets manufactured by GlaxoSmithKline, and the efavirenz tablets are a version of Sustiva tablets manufactured by Bristol Myers-Squibb.

A Tentative Approval means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, though it may not yet be marketed in the U.S. due to existing patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) program.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration