real-time news and commentary for investors
Monday, Aug 19
Supernus' epilepsy treatment gets final FDA approval
- Supernus (SUPN) receives final FDA approval for Trokendi XR, the company's once-daily treatment for epilepsy.
- Supernus intends to launch the product in the next few weeks.
- The FDA granted a waiver for certain requirements related to a pediatric study, and a "deferral for submission of post-marketing pediatric pharmacokinetic assessments that are due in 2019 followed by clinical assessments in 2025."
- Shares +10.7%. (PR)