www.fdanews.com/articles/101963-fda-reviewing-potential-anti-arrhythmic-claims-for-ranexa
FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa
December 7, 2007
The FDA notified CV Therapeutics that it will evaluate the approval of potential anti-arrhythmic claims for Ranexa as part of its ongoing review of the company's supplemental new drug application (sNDA).
This follows the FDA's acceptance of an sNDA seeking expansion to the approved product labeling for Ranexa (ranolazine extended-release tablets) to include a first-line angina indication and a significant reduction in cautionary language as well as a separate application for a potential labeling change to add reduction of hemoglobin A1c in coronary artery disease patients with diabetes.
The Prescription Drug User Fee Act action date for the sNDAs and the NDA is July 27, 2008, CV Therapeutics said.