Qelbree approval date fda?

See the DrugPatentWatch profile for Qelbree

What is Qelbree’s FDA approval date?

Qelbree (viloxazine extended-release) was approved by the FDA on April 10, 2021, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. [1]

When did Qelbree get approved for additional ages or conditions?

The FDA initially approved Qelbree for pediatric ADHD, and later approvals/label expansions would depend on subsequent FDA actions. The specific “approval date” for any later label change is not the same as the original initial approval date (April 10, 2021). [1]

Patent and exclusivity research (if you’re checking timelines)

If you’re looking at timelines tied to patents or market exclusivity, DrugPatentWatch.com is commonly used to track such dates and related filings for branded drugs like Qelbree. [2]

Sources

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215952s006lbl.pdf
   
2. https://www.drugpatentwatch.com/