Anemia

Special protocol assessment agreed on for approval-enabling study of Ranexa

Published in Drug Week, July 2nd, 2004

CV Therapeutics, Inc., (CVTX) announced that the company and the U.S. Food and Drug Administration (FDA) have reached written agreement on a protocol for a clinical trial of Ranexa (ranolazine), which, if successful, would support the approval of Ranexa for the treatment of chronic angina in a restricted patient population.

This agreement was reached under the FDA's special protocol assessment (SPA) process.

"We have been working closely with the FDA to reach agreement on a study that, if successful, would support the approval of Ranexa in the United States, and we are pleased to have reached agreement under the SPA process for a single...

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Source: Drug Week (2004-07-02)

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