Supernus announces FDA label update for Qelbree with new pharmacodynamic and lactation data

SUPERNUS PHARMACEUTICALS, INC.

FDA approved updated Qelbree label including serotonin 5-HT2C partial agonist activity and norepinephrine transporter inhibition data.
New lactation data show transfer of viloxazine into breastmilk is low; relative infant dose ~1% of maternal dose.
Qelbree is first ADHD treatment to receive labeling approval under 2019 FDA guidance on Clinical Lactation Studies.
Label update applies to Qelbree (viloxazine extended-release capsules) for ADHD in patients 6 years and older.
Company cites commitment to building evidence for Qelbree use in ADHD.

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