Drug Development

Amendment submitted to U.S. FDA for Ranexa (ranolazine) NDA

Published in Medical Letter on the CDC and FDA, September 4th, 2005

CV Therapeutics, Inc., (CVTX) announced that it has submitted an amendment to the new drug application (NDA) for Ranexa (ranolazine) to the U.S. Food and Drug Administration (FDA) seeking approval for the treatment of chronic angina in a restricted patient population.

This amendment is intended to provide a complete response to the approvable letter received in October 2003, based on results from the recently completed Evaluation of Ranolazine In Chronic Angina (ERICA) study, which was conducted under the FDA's special protocol assessment (SPA) process and met its primary endpoint.

The NDA, if approved, could enable the potential launch of Ranexa in...

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Source: Medical Letter on the CDC and FDA (2005-09-04)

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