Qelbree FDA Approval History
Last updated by Judith Stewart, BPharm on May 1, 2022.
FDA Approved: Yes (First approved April 2, 2021)
Brand name: Qelbree
Generic name: viloxazine hydrochloride
Dosage form: Extended Release Capsules
Company: Supernus Pharmaceuticals, Inc.
Treatment for: ADHD
Qelbree (viloxazine hydrochloride) is a serotonin norepinephrine modulating agent (SNMA) for the treatment of attention deficit hyperactivity disorder (ADHD) in in adults and pediatric patients 6 years and older.
- Qelbree is a non-stimulant, and it is not a controlled substance.
- Qelbree capsules are taken once daily.
- Qelbree may increase suicidal thoughts and actions in some children with ADHD, especially within the first few months of treatment or when the dose is changed. Patients should be carefully monitored, and any new or sudden changes in mood or behavior should be reported right away.
- Common side effects in pediatric patients include somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability. Common side effects in adults include insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth and constipation.
Development timeline for Qelbree
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