AIDS Therapy

FDA accepts Coviracil NDA for the treatment of HIV

Published in AIDS Weekly, December 2nd, 2002

Triangle Pharmaceuticals, Inc., (VIRS) announced that the U.S. Food and Drug Administration (FDA) has notified the company that its new drug application (NDA) for marketing approval of Coviracil for the treatment of HIV disease has been accepted for filing.

Filing of the NDA is recognition by the FDA that the application is sufficiently complete for review.

"We are very pleased with this notification," commented Daniel G. Welch, chairman and CEO of Triangle. He continued, "Consistent with our previous guidance when we submitted our NDA, the FDA granted Coviracil a standard review. This means that as early as the third quarter of 2003, we hope to...

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Source: AIDS Weekly (2002-12-02)

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