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Angina
Trial of Ranexa initiated for certain patients with chronic angina
September 5th, 2004
CV Therapeutics, Inc., (CVTX) announced that it has initiated an approval-enabling study of Ranexa, which, if successful, could support approval of Ranexa for the treatment of chronic angina in a restricted patient population. The study is being conducted under the U.S. Food and Drug Administration's (FDA) special protocol assessment (SPA) process, as announced on June 2, 2004. "We are very excited to have initiated this approval-enabling study," said Louis G. Lange, MD, PhD, chairman and chief executive officer of CV Therapeutics, Inc. "In addition to the SPA agreement we have in place for this study, we also have a second SPA in...
Source: Medical Letter on the CDC & FDA (2004-09-05)
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