Food and Drug Administration - March 31, 2009
Richard Klein & Kimberly Struble

On March 30, FDA granted tentative approval for emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, manufactured by Matrix Laboratories Ltd. of of Hyderabad, India,under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR)

FDA has determined that the Matrix Laboratories generic formulation is bioequivalent and, therefore, therapeutically equivalent to Truvada Tablets, 200 mg/300 mg, made by Gilead Sciences Inc. However, existing patent protections and pediatric exclusivity for Truvada prevent final approval of a generic formulation. Effective patent dates can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"

"Tentative approval" means that while FDA has concluded that a drug product has met all required quality, safety and efficacy standards, because of the existing patents and/or exclusivity rights, is not eligible for marketing in the U.S.. However, tentative approval does make the product eligible for consideration for purchase under the PEPFAR program.

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.

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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SOURCE: Food and Drug Administration (FDA).

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