FDA approves Qelbree to treat ADHD

6 April 2021

Supernus Pharmaceuticals (Nasdaq: SUPN) saw its shares rise 7.2% to $26.72 in pre-market trading today, after the US biotech late on Friday announced that the US Food and Drug Administration has approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients six to 17 years of age.

This was a welcome development for Supernus, which in November last year received a Complete Response Letter (CRL) for SPN-812 (viloxazine hydrochloride; SPN-812) from the FDA, for the treatment of children with ADHD.

The agency primarily raised concerns over Supernus’ in-house laboratory, which the firm said “recently moved to a new location.” Prior to that, the firm received a Refusal to File (RTF) letter from the FDA regarding its submission for this candidate.

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