Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
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Food and Drug Administration - August 28, 2006
Richard Klein & Kimberly Struble
FDA's tentative approval means that although the 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 this 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.
This product is a generic version of Zerit Capsules, 30 mg and 40 mg, a nucleoside reverse transcriptase inhibitor (NRTI) used in combination with other antiretroviral agents for the treatment of HIV-1 infection, manufactured by Bristol-Myers Squibb.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
060828
FD060802
SOURCE: Food and Drug Administration (FDA).
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