Supernus receives FDA Complete Response Letter for SPN-830 (apomorphine infusion device)

SUPERNUS PHARMACEUTICALS, INC.

FDA issued CRL stating NDA for SPN-830 (apomorphine infusion) not ready for approval.
Two areas: product quality (additional data submitted but not reviewed) and device master file from manufacturer.
No clinical safety or efficacy issues identified as barriers to approval.
FDA completed successful preapproval inspection of device manufacturer's facility in Feb 2024.
Supernus plans to work with device manufacturer and FDA to resubmit NDA.

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