FDA Grants Tentative Approval of Generic Fixed-dose Combination of Efavirenz/emtricitabine/tenofovir

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On August 12, 2009, the U.S. Food and Drug Administration (FDA) granted tentative approval for a generic fixed-dose combination pill containing 600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir -- equivalent to the brand-name Atripla coformulation.

The new product, manufactured by Matrix Laboratories Limited of Hyberdad, India, is indicated for use alone or in combination with other antiretroviral products for the treatment of HIV-1 infection in adults. It will likely be used in a similar manner to Gilead Science's Atripla, as a complete once-daily first-line regimen for treatment-naive patients.

"Tentative approval" means that the FDA has concluded that a drug product meets all requiredquality, safety, and efficacy standards. However, it is not eligible for final approval or marketing in the U.S. due to existing patents and/or exclusivity rights.

Tentative approval does make the product eligible for purchase outside the U.S. under the President's Emergency Plan for AIDS Relief (PEPFAR). Patent information for this and other approved products is available in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (known as the "Orange Book").

As with all generic applications, FDA conducted 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 tentative approval.

A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA web site.

8/18/09

Source

Richard Klein (Office of Special Health Issues, Food and Drug Administration) and Kimberly Struble (Division of Antiviral Drug Products, Food and Drug) Administration). Announcement. August 12, 2009.