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On December 12, 2008, FDA granted tentative approval for efavirenz 100 mg scored tablets, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection, facilitating pediatric treatment. The product is manufactured by Aurobindo Pharma Limited, Hyberdad, India.
Efavirenz is an antivral agent in the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) class.
"Tentative approval" means that FDA has concluded that a drug product meets 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. However, tentative approval does make the product eligible for purchase outside the United States under the President’s Emergency Plan for AIDS Relief (PEPFAR) .
The application was reviewed under expedited review provisions developed by FDA for the PEPFAR program
This tentative approval is a generic version of Sustiva, which is a product of Bristol Myers-Squibb, and is subject to existing patent protection. 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"
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 list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan 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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