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
Click here to read full press release/ article | Ref: Globalnewswire | Image: Supernus
The post Supernus’ Qelbree (SPN-812) Receives the US FDA’s Approval for the Treatment of ADHD first appeared on PharmaShots.
