On August 3, 2009, the Food and Drug Administration granted tentative approval for a generic formulation of efavirenz capsules, 200 mg, manufactured by Cipla, Limited, of Mumbai, India, indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The application was 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 patent protections. Tentative approval does, however, make the product eligible for consideration for purchase outside the United States under the PEPFAR program.
This product is a generic version of Sustiva capsules, 200 mg, a Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI), manufactured by Bristol Myers-Squibb. Effective patent dates can be found in the FDA 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.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
