Two tentative approvals

On March 13, 2007, FDA granted tentative approval for two applications for antiretroviral drugs products made by Strides Acrolab Ltd., Bangalore, India, under the expedited review provisions created by FDA for the President's Emergency Plan for AIDS Relief (PEPFAR).

The first is a fixed dose combination of stavudine/lamivudine (40mg/150mg) tablets, co-packaged with nevirapine tablets  (200mg) for use in HIV-1 treatment  of HIV-1.

The second is a fixed dose combination of Stavudine/Lamivudine (40mg/150mg) Tablets for use in HIV-1 treatment in combination with other antiretroviral drugs. These products represent drug combinations which can significantly decrease pill burden and could result in improved compliance for HIV infected individuals.

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 exclusivity currently prevent marketing of the product in the United States.  Tentative approval, however, qualifies the product for consideration for purchase under the PEPFAR program.

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.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration