Important note: Information in this article was accurate in July 2006. The state of the art may have changed since the publication date.
FDA approves four new generic products for use in PEPFAR
HIV Treat Bull - Vol. 7, No. 7/8, July/August 2006
In June 2006, the Food and Drug Administration (FDA) granted tentative approval for the following Indian generic products:
The FDA’s tentative approval of these products means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product meets all of FDA’s safety, efficacy, and manufacturing quality standards required for marketing in the U.S. It will now be available for consideration for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR).
Source:
2008-03-10
IB060707-23
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