ROCKVILLE, Md. — The Food and Drug Administration has given tentative approval to Supernus Pharmaceuticals for a drug to treat epilepsy, the company said Tuesday.
Supernus announced the tentative approval was given to Trokendi XR (topiramate), a once-daily treatment for the seizure disorder. The company said final approval was conditioned on resolution of market exclusivity issues concerning certain pediatric populations.
"We are pleased to announce that the FDA has granted us tentative approval for Trokendi XR and that all of the scientific and procedural conditions for approval have been met," Supernus CEO, president and director Jack Khattar said. "We will continue to work closely with the FDA to further understand the outstanding issue and move forward toward final approval."