CV Therapeutics Inc has received an approvable letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Ranexa (ranolazine) for the treatment of chronic angina. The Cardiovascular and Renal Drugs Advisory Committee is scheduled to review Ranexa on December 9, 2003.
CV Therapeutics understands, based on discussions with the FDA, that the purpose of the advisory committee meeting is to determine whether the committee considers the current NDA sufficient to support approval of Ranexa. In the approvable letter, the FDA indicated that there is evidence that Ranexa is an effective anti-anginal, and that additional clinical information is needed prior to approval. We understand that the FDA may be prepared to reevaluate this requirement based on the results of the advisory committee review. The FDA is not required to follow the recommendations of the advisory committee.
None of CV Therapeutics' products have been approved for marketing by the FDA or foreign regulatory agencies. Any products of the company discussed here are currently under investigation in clinical trials subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States. CV Therapeutics' products have not been determined to be safe or effective in humans for any uses.