Food and Drug Administration - March 19, 2009
Richard Klein & Kimberly Struble

The Food and Drug Administration, on March 18, 2009, granted tentative approval for stavudine and lamivudine fixed dose combination tablets, 30mg/150mg & 40mg/150mg, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection as a component of combination therapy. Fixed dose combination products such as this can ease pill burden and simplify dosing, and can help increase drug adherence.

Stavudine and lamivudine are Nucleoside Reverse Transcriptate Inhibitors (NRTIs), a class of antiretroviral drugs that inhibit reverse transcriptase, a viral enzyme necessary for replication of the human immunodeficiency virus, or HIV.

Tentative approval means that even though the product has been shown to meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents prevent marketing of this fixed dose combination product in the United States, so it is not eligible for final approval. Tentative approval, however, qualifies this product for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) outside of the U.S.

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.

The product application, submitted by Aspen Pharmacare Limited, of Port Elizabeth, South Africa, was reviewed under expedited review provisions for PEPFAR, A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA website.

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SOURCE: Food and Drug Administration (FDA).

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