Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.CV Therapeutics has said that its supplemental new drug application and new drug application for antianginal treatment Ranexa have both been accepted for filing by the FDA.
Subscribe to our email newsletter
The Prescription Drug User Fee Act action date for both applications is July 27, 2008.
The supplemental new drug application (sNDA) seeks an 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. The sNDA is being reviewed by the FDA’s division of cardiovascular renal products.
After receiving the sNDA submission, the FDA initiated, and has now accepted for filing, a separate new drug application (NDA) on behalf of the company to provide a clinical review of a potential labeling change to add reduction of hemoglobin A1c in coronary artery disease patients with diabetes. This NDA is being reviewed by the FDA’s division of metabolism and endocrinology products.
In accordance with a special protocol assessment agreement between the FDA and CV Therapeutics, the company believes that data from the Merlin TIMI-36 study could support expansion of the existing Ranexa indication to first line angina.
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.
Louis Lange, chairman and CEO of CV Therapeutics, said: “With the Ranexa sNDA and NDA now accepted for filing, the NDA under review for regadenoson and our marketing authorization application for ranolazine under review in Europe, we are very excited to have several major applications in process and are looking forward to multiple potential approvals in 2008.”