Posted by Michael Wonder on 21 Oct 2016
Teva announces FDA acceptance of resubmitted new drug application for SD-809 for treatment of chorea associated with Huntington disease
20 October 2016 - Teva Pharmaceutical Industries Ltd today announced that the U.S. FDA has accepted the resubmission of the new drug application for SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease.
The FDA has assigned a PDUFA goal date of 3 April 2017.
SD-809 was granted orphan drug designation for the treatment of Huntington disease by the FDA in November 2014. The NDA filing is based on results from two Phase-III studies, FIRST-HD and ARC-HD.
The resubmission of the NDA follows the receipt of a complete response letter from the FDA in May 2016.
