FDA Accepts Ranexa sNDA and NDA for Filing

The FDA notified CV Therapeutics it has accepted the company’s supplemental new drug application (sNDA) and new drug application (NDA) for Ranexa.

The sNDA seeks an expansion to the approved product labeling for Ranexa (ranolazine extended-release tablets) to include a first-line angina indication and a reduction in cautionary language. CV Therapeutics said data from the MERLIN TIMI-36 study could support the expansion of the indication to include first-line angina.

The agency accepted a separate NDA to provide a clinical review of 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 both applications is July 27, 2008.