Supernus Pharmaceuticals (SUPN) Provides Update on the Launch of Its Two Epilepsy Products Trokendi XR(TM) and SPN-804
7/13/2012 9:55:53 AM
ROCKVILLE, Md., July 13, 2012 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceuticals company, announced on June 26 that it received a tentative approval letter from the Food & Drug Administration (the "FDA") for Trokendi XR™, a once-daily extended release formulation of topiramate (formerly known as SPN-538). The letter states that the FDA completed its review of the Trokendi XR NDA and that no additional clinical trials are required. The letter also states that final approval may not be made effective by the FDA until the period of exclusivity protection associated with safety information regarding a specific pediatric population expires.