AEGiS-FDA: Tentative approval of new triple drug Fixed dose combination

Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.

Tentative approval of new triple drug Fixed dose combination

Food and Drug Administration - November 20, 2006
Richard Klein & Kimberly Struble

On November 17, 2006, the Food and Drug Administration (FDA) granted tentative approval for a new fixed drug combination of stavudine/lamivudine/nevirapine tablets manufactured by Cipla Limited, of Mumbai, India. This product was reviewed under expedited procedures for the President's Emergency Plan for AIDS Relief (PEPFAR) program.

Stavudine, lamivudine, and nevirapine are anti-viral drugs for the treatment of HIV-1 infection. This product represents a new combination which can significantly decrease pill burden and could result in improved compliance for HIV infected individuals.

FDA's tentative approval of this product means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product has been shown to meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and thus qualifies for consideration for purchase under PEPFAR.

Richard Klein | Office of Special Health Issues | Food and Drug Administration

Kimberly Struble | Division of Antiviral Drug Products | Food and Drug Administration

061120
FD061102

SOURCE: Food and Drug Administration (FDA).

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