- Company to File sNDA Seeking Expanded Ranexa(R) Labeling with Reduced Cautionary Language - PALO ALTO, Calif., April 24 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX) announced today that data from the MERLIN TIMI-36 study will be published in this week's issue of The Journal of the American Medical Association (JAMA). The Company plans to ask the U.S. Food and Drug Administration (FDA) to modify the existing product labeling for Ranexa(R) (ranolazine extended-release tablets) by reducing cautionary language and expanding the indication to include first-line angina. The data and results published in JAMA from the MERLIN TIMI-36 study showed that patients with acute coronary syndromes (ACS) receiving Ranexa had no adverse trend in death or arrhythmias and had statistically significant reductions of clinically significant arrhythmias (p
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