FDA accepts Teva's resubmission of SD-809 NDA

21 October 2016

The US Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application 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, said Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA), which is developing the compound.

Back in June, the FDA issued a complete response letter regarding the NDA, asking Teva to examine blood levels of certain metabolites. SD-809 became part of Teva’s central nervous system product portfolio with the $3.2 billion acquisition of Auspex Pharmaceuticals, completed in May 2015.

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