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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

Sep 10, 2023Supernus Announces New Qelbree Data Showing Improvement in ADHD Symptom
Apr 29, 2022Approval Supernus Announces FDA Approval of Qelbree for the Treatment of ADHD in Adults
Apr  2, 2021Approval FDA Approves Qelbree (viloxazine) for the Treatment of ADHD
Feb  8, 2021Supernus Resubmits New Drug Application for SPN-812 for the Treatment of ADHD in Pediatric Patients
Nov  9, 2020Supernus Provides Regulatory Update for SPN-812
Nov  9, 2020Supernus Provides Regulatory Updates for SPN-812 and SPN-830
Jan 22, 2020Supernus Announces FDA Acceptance for Review of New Drug Application for SPN-812 (viloxazine hydrochloride) for the Treatment of ADHD
Nov 11, 2019Supernus Submits New Drug Application for SPN-812 for the Treatment of ADHD
Dec  6, 2018Supernus Announces Positive Results from Two Phase III Studies For SPN-812 in Children with ADHD

Further information

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