Supernus soars on tentative ER topiramate approval

Supernus Pharmaceuticals Inc. (NASDAQ:SUPN) jumped $6.52 (114%) to $12.23 on Tuesday after FDA granted tentative approval of an NDA for Trokendi XR (formerly SPN-538) to treat epilepsy. Supernus said final approval of the extended-release formulation of topiramate is contingent on resolving a market exclusivity issue raised by FDA regarding a specific pediatric population. Supernus submitted the application under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows the company to reference existing data on safety and efficacy for Topamax, an immediate-release topiramate formulation marketed by Johnson & Johnson (NYSE:JNJ). ...