CV Therapeutics, Inc. announced today that it has been informed by the U.S. Food and Drug Administration (FDA) that it is continuing its review of CV Therapeutics' pending applications for Ranexa(R) (ranolazine extended-release tablets) past the Prescription Drug User Fee Act (PDUFA) action date of July 27, 2008. The applications seek a first line angina indication and promotable claims for the reduction of hemoglobin A1c (HbA1c) and ventricular arrhythmias in patients with coronary artery disease. The FDA has informed CV Therapeutics that the Company should receive draft labeling in the next few weeks, and the Company plans to promptly communicate when the labeling is complete.
The details can be read here.
No comments:
Post a Comment