Tentative approval of nevirapine tablets for oral suspension, 50 mg and 100 mg for pediatric use

On April 30, 2012, the Food and Drug Administration granted tentative approval for nevirapine scored tablets for oral suspension, 50 mg and 100 mg, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in pediatric patients weighing at least 5 kg.

The product is manufactured by Cipla Limited of Mumbai, India.

FDA's tentative approval means that although a product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents and/or proprietary issues currently prevent marketing of the product in the United States. Tentative approval does, however, qualify the product for consideration for purchase under the President's Emergency Plan for AIDS Relief, or PEPFAR program.

As with all generic applications, FDA conducts an on-site inspection of the manufacturing facilities and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application. 

You can find a complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan on the FDA web site.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration