Posted by Michael Wonder on 22 Feb 2021
Supernus receives FDA notice assigning early April 2021 PDUFA date for SPN-812 NDA
22 February 2021 - Supernus Pharmaceuticals today announced that it received notice from the U.S. FDA that the company’s new drug application resubmission for SPN-812 for the treatment of ADHD in paediatric 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 target action date in early April 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 to the FDA for SPN-812 for the treatment of ADHD in adult patients in the second half of 2021, assuming approval for paediatric patients.
