PETAH TIKVA (dpa-AFX) - Teva Pharmaceutical Industries Ltd. (TEVA) announced 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 April 3, 2017.
SD-809 was granted Orphan Drug Designation in November 2014. The resubmission of the NDA follows the receipt of a Complete Response Letter from the FDA in May 2016.
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