Posted by Michael Wonder on 22 Jan 2020
Supernus announces FDA acceptance for review of new drug application for SPN-812 for the treatment of ADHD
21 January 2020 - PN-812 (viloxazine hydrochloride), a once-daily novel serotonin norepinephrine modulating agent, demonstrates a reduction in ADHD-RS-5 total score as early as Week 1 and continuing until the end of the pivotal clinical studies.
Supernus Pharmaceuticals today announced that the U.S. FDA has found the new drug application for SPN-812 for the treatment of children and adolescents with attention deficit hyperactivity disorder acceptable for review.
The FDA has assigned a Prescription Drug User Fee Act target action date of 8 November 2020.
