The FDA accepts for review Supernus Pharmaceuticals’ (NASDAQ:SUPN) marketing application seeking approval of SPN-812 for the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD).
The agency’s action date is November 8.
SPN-812 is a serotonin norepinephrine modulating agent that has been marketed for many years in Europe as an antidepressant. It has never been approved for any indication in the U.S.
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