FDA Approves New Mechanism Of Action Labeling For Ranexa
FDA has approved CV Therapeutics' language for the product labeling for Ranexa (ranolazine extended-release tablets) which describes the ability of ranolazine to inhibit the late sodium current at therapeutic levels.
Published data on ranolazine's mechanism suggests that during ischemic episodes excess sodium can flow into cardiac cells through sodium channels. This excess sodium can trigger a subsequent overload of calcium that can lead to problems with proper contraction and relaxation of the heart. Late sodium current inhibition has been shown to improve mechanical and electrical dysfunctions of cardiac cells under these circumstances.
"We believe it is important for physicians to have as much information as possible on the mechanism of action for Ranexa and we are very pleased that the FDA has worked with us to add this new language to the approved product labeling," said Louis G. Lange, CV Therapeutics chairman and chief executive officer.