Business UpdateJul 14, 2026, 08:32 AM
Supernus Celebrates 5-Year Anniversary of Qelbree FDA Approval
AI Summary
Supernus Pharmaceuticals is celebrating the five-year anniversary of the U.S. FDA approval of Qelbree (viloxazine extended-release capsules) for attention-deficit/hyperactivity disorder (ADHD). Since its initial approval for pediatric ADHD in April 2021 and subsequent approval for adults in April 2022, Qelbree has seen approximately 3 million prescriptions filled, with over 1 million in 2025 alone. The company highlights Qelbree's differentiated approach as the first novel, non-stimulant ADHD medication in over a decade, offering 24-hour exposure and no evidence of abuse potential.
Key Highlights
- Qelbree celebrates its five-year anniversary since FDA approval for ADHD.
- Approximately 3 million Qelbree prescriptions have been filled since launch.
- Over 1 million Qelbree prescriptions were filled in 2025 alone.
- Qelbree was first approved for pediatric ADHD in April 2021.
- Expanded FDA approval for adult ADHD was secured in April 2022.
- FDA labeling updates in January 2025 included pharmacodynamic and lactation data.
- Qelbree is the first novel, non-stimulant ADHD medication approved in over a decade.
Price Impact
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