Supernus battles back from CRL, scoring the FDA's approval for non-stimulant ADHD med Qelbree
After a harsh slapdown last fall, US regulators are now singing a different tune on Supernus Pharmaceuticals’ “sprinkleable” ADHD drug.
The FDA on Friday approved SPN-812 — now marketed as Qelbree — as a non-stimulant treatment for ADHD in kids 6 to 17 years old. And with new data in hand for adult patients, the company plans on filing a supplemental NDA in the second half of this year.
Regulators initially rejected Supernus’ application for Qelbree back in November at the same time they issued an RTF for SPN-830, a continuous treatment pump meant for Parkinson’s disease.
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