The FDA has notified CV Therapeutics that its supplemental new drug application (sNDA) and new drug application (NDA) for Ranexa (ranolazine extended- release tablets) have both been accepted for filing.
The Prescription Drug User Fee Act action date for both applications is July 27, 2008.
The Palo Alto, Calif.-based CV Therapeutics said the sNDA seeks an expansion to the approved product labeling for Ranexa to include a first line angina indication and a significant reduction in cautionary language. The FDA division of cardiovascular renal products is reviewing the sNDA for Ranexa.
Ranexa is currently indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates, according to the company.