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Generic FDC EFV/3TC/TDF Approved by FDA
  On September 3, 2009, FDA granted tentative approval for a generic fixed-does combination tablet containing efavirenz, lamivudine, and tenofovir disoproxil fumarate, 600mg/300mg/300mg. This new fixed-dose combination is manufactured by Matrix Laboratories Limited of Hyberdad, India. It is indicated for use alone or in combination with other antiretroviral products for the treatment of HIV-1 infection.
"Tentative approval" means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not presently eligible for final approval or marketing in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for purchase outside the United States 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, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.
A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plancan be found on the FDA web site. 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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