PALO ALTO, Calif., Sept. 27 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) 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(R) (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.
About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases.
CV Therapeutics' approved product, Ranexa(R) (ranolazine
extended-release tablets), is indicated for the treatment of chronic angina
in patients who have not achieved an adequate response with other
|SOURCE CV Therapeutics, Inc.|
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