Teva Pharma (TEVA) Announces FDA Acceptance of Resubmitted NDA for SD-809 for Treatment of Chorea Associated with HD
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Teva Announces FDA Acceptance of Resubmitted New Drug Application for SD-809 for Treatment of Chorea Associated with Huntington Disease
October 20, 2016 9:00 AM EDTJERUSALEM--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 3, 2017.
We are delighted to share the news of this step in the regulatory process with the Huntington disease community, said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief... More
