On February 24, 2010, the Food and Drug Administration (FDA) granted tentative approval for nevirapine tablets for oral suspension, 50 mg, manufactured by Aurobindo Pharma Ltd.of Hyderabad, India, indicated in pediatric patients weighing at least 5 kg, in combination with other antiretrovirals for the treatment of HIV-1 infection.
Tentative approval means that FDA has concluded that a drug product has met all of the required quality, safety and efficacy standards, even though it may not yet be marketed in the U.S. due to existing patents and/or exclusivity. It does, however, make the product eligible for use under the President's Emergency Plan for AIDS Relief (PEPFAR) program outside the United States.
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.
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.
Nevirapine is a Nonnucleoside Reverse Transcriptase Inhibitors (NNRTI).
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm
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