Supernus Pharma (SUPN) Receives FDA Notice Assigning Early April 2021 PDUFA Date for SPN-812 NDA
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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.
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