PALO ALTO, Calif., Nov 19 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that its supplemental new drug application (sNDA) and new drug application (NDA) for Ranexa(R) (ranolazine extended- release tablets) have both been accepted for filing. The Prescription Drug User Fee Act (PDUFA) action date for both applications is July 27, 2008.
The sNDA seeks an expansion to the approved product labeling for Ranexa(R) (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 Division of Cardiovascular Renal Products.
After receiving this sNDA submission from CV Therapeutics, the FDA initiated, and has now accepted for filing, a separate NDA on behalf of the Company to provide a clinical review of a potential labeling change to add reduction of hemoglobin A1c (HbA1c) in coronary artery disease patients with diabetes. This NDA is being reviewed by the FDA Division of Metabolism and Endocrinology Products.
"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," said Louis G. Lange, CV Therapeutics chairman and chief executive officer.
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
|SOURCE CV Therapeutics, Inc.|
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