FDA approves Supernus' epilepsy drug

FDA approved Oxtellar XR from Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) as an adjunctive therapy for epilepsy in adults and children 6-17 years old. The company plans to launch the once-daily extended-release formulation of oxcarbazepine in 1Q13.

Oxtellar XR (formerly SPN-804) is Supernus' second epilepsy product to be approved by FDA since the company raised $50 million in May in an IPO. In June, FDA granted tentative approval to Trokendi XR (formerly SPN-538). Supernus plans to launch the extended-release formulation of topiramate in 3Q13 following final approval, which is contingent on resolving a market exclusivity issue raised by FDA regarding a specific pediatric population (see BioCentury Extra, June 26). ...