Journal of the American Medical Association Publishes MERLIN TIMI-36 Results
April 24 2007 - 5:00PM
PR Newswire (US)
- 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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