Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
Food and Drug Administration - November 6, 2006
Richard Klein & Kimberly Struble
FDA's tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and can thus be considered for purchase under PEPFAR.
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 tentatively approved product, a generic version of Ziagen tablets manufactured by GlaxoSmithKline, is a nucleoside reverse transcriptase inhibitor (NRTI) for use in combination with other antiretroviral agents in the treatment of HIV infection.
Richard Klein | Office of Special Health Issues | Food and Drug Administration
Kimberly Struble | Division of Antiviral Drug Products | Food and Drug Administration
061106
FD061101
SOURCE: Food and Drug Administration (FDA).
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