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Biotech / Medical : CVTX - CV Therapeutics, Inc.
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To: mopgcw who wrote (316)9/27/2007 4:51:47 PM
From: keokalani'nui  Read Replies (2) of 411
 
CV Therapeutics Submits Supplemental New Drug Application for Ranexa(R) (ranolazine extended-release tablets)
Thursday September 27, 4:01 pm ET

PALO ALTO, Calif., Sept. 27 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) announced today that the Company has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking an expansion to the approved product labeling for Ranexa® (ranolazine extended-release tablets).

The submitted sNDA requests a new indication for first line treatment of chronic angina and a significant reduction in cautionary language, based on substantial data from the MERLIN TIMI-36 study.

"We believe that this new labeling, if approved, should position Ranexa as safe and effective for use in a broader population," said Louis G. Lange, CV Therapeutics chairman and chief executive officer.

In accordance with a special protocol assessment agreement between the FDA and CV Therapeutics, the Company believes that data from the MERLIN TIMI-36 study could support expansion of the existing Ranexa indication to first line angina.

Ranexa is currently indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates.
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