FDA accepts NDA for tasimelton for Non 24 Hour Disorder

The FDA has accepted the new drug application (NDA) from Vanda Pharma for tasimelteon to treat Non-24-Hour Disorder, a sleep awake disorder.The FDA has also granted the application a priority review.

The FDA has set 31 January 2014 as the Prescription Drug User Fee Act action date and also has tentatively scheduled a 14 November advisory committee meeting to discuss the NDA for tasimelteon. Tasimelteon is a new chemical entity, and a circadian regulator to treat Non-24-Hour Disorder (non-24) in patients with total blindness.