FDA approves Vanda's Hetlioz

FDA approved an NDA for Hetlioz tasimelteon ( VEC-162) from Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) to treat non-24-hour sleep wake disorder in totally blind patients. FDA said it is the first approved treatment for the indication. Vanda said it is "premature" to discuss the price of Hetlioz but that it plans to launch the drug in the U.S. next quarter. The company plans to submit an application for the melatonin MT1 and MT2 receptor agonist in the EU this year. Vanda has exclusive, worldwide rights to tasimelteon from Bristol-Myers Squibb Co. (NYSE:BMY). ...