FDA Responds to Teva’s NDA with Complete Response Letter for Huntington’s Chorea Drug
Teva Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) answering the pharmaceutical’s New Drug Application (NDA) for SD-809 (deutetrabenazine) tablets, for the treatment of chorea associated with Huntington’s disease (HD), a condition reported by nearly 90 percent of all Huntington’s…