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Treats Attention-Deficit Hyperactivity Disorder (ADHD). Sold as Qelbree. Every FDA application for this active ingredient: 1 branded and 2 generic.
As of Nov 15, 2026, FDA lists 3 applications for Viloxazine Hydrochloride (sold as Qelbree), first approved Apr 2, 2021, with 1 new use approved and 1 published complete response letter.
First approved: Apr 2, 2021
Applications: 3
New uses approved: 1
Complete response letters: 1
Medicare spending, 2025: $9.9M
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Product
Part
Spending, 2025
Change
Beneficiaries
Qelbree
Part D
$9.9M
+46%
4,019
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
QELBREE ER 100 MG CAPSULE: $12.73 per unitBrand · +6% in a year
QELBREE ER 150 MG CAPSULE: $12.73 per unitBrand · +6% in a year
QELBREE ER 200 MG CAPSULE: $12.73 per unitBrand · +6% in a year
Clinical Trials
4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA