Supernus' Qelbree (SPN-812) Receives the US FDA's Approval for the Treatment of ADHD
Shots:
- The approval is based on data from an extensive development program that consists of four P-III clinical trials evaluating Qelbree in 1000+ pediatric patients aged 6 to 17 yrs. with ADHD
- The program demonstrated the proven efficacy and a tolerable safety profile. In Dec’2020- the company reported the results from the P- III trial for Qelbree and plans to submit an sNDA to the FDA in H2’21
- Qelbree is the first novel non-stimulant treatment for ADHD. The company plans to make it available in the US in Q2’21
Ref: Globalnewswire | Image: Supernus
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