The NDA for SPN-830 is supported by data from an extensive development program that includes the phase 3 TOLEDO study and a supportive open-label study. The New Drug Application (NDA) for SPN-830 ...
A Prescription Drug User Fee Act target date of February 1, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) ...
ROCKVILLE, Md., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of ...