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Tentative approvals of generic stavudine and efavirenz

Food and Drug Administration - March 3, 2008
Richard Klein & Kimberly Struble

On February 29, 2008, FDA granted tentative approval for two generic formulations of drugs used to treat HIV/AIDS. Stavudine capsules, 15 mg, 20 mg, 30 mg, and 40 mg., and efavirenz tablets, 600 mg, all manufactured by Hetero Drugs Limited, Hyberdad, India, were tentatively approved for use in combination with other antiretrovirals in the treatment of HIV infection. The applications were reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR)

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

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"

These tentative approvals are generic versions of Zerit (stavudine) capsules, a Nucleoside Reverse Transcriptase Inhibitor (NRTI), 15 mg, 20 mg, 30 mg, and 40 mg, and Sustiva (efavirenz) tablets, a Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI), 600 mg. Both Zerit and Sustiva are products of Bristol Myers Squibb.

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.

A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan (PEPFAR) is available on the FDA website.

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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