Supernus Receives FDA Notice Assigning Early April 2021 PDUFA Date for SPN-812 NDA

About this update from Supernus Pharmaceuticals, Inc.

ROCKVILLE, Md., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that it received notice from the U.S. Food and Drug Administration (FDA) that the company’s New Drug Application (NDA) resubmission for SPN-812 for the treatment of ADHD in pediatric patients is considered a Class I resubmission thereby assigning a timeline of two months for review by the FDA and establishing a new Prescription Drug User Fee Act (PDUFA) target action date in early April 2021. Supernus will continue to work closely with the FDA as it completes its review of the SPN-812 NDA. If approved by the FDA, the Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021. In December 2020, Supernus announced positive results from a Phase III study for SPN-812 in adults with ADHD. The Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 for the treatment of ADHD in adult patients in the second half of 2021, assuming approval for pediatric patients. About Supernus Pharmaceuticals, Inc. Supernus Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, hypomobility in Parkinson’s disease, cervical dystonia and chronic sialorrhea. We are developing a broad range of novel CNS product candidates including new potential treatments for attention-deficit hyperactivity disorder (ADHD), hypomobility in Parkinson’s disease, epilepsy, depression, and rare CNS disorders. For more information, please visit www.supernus.com. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information, but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These forward-looking statements includ...

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