Tuesday, June 26, 2012

Supernus (Nasdaq: SUPN) epilepsy drug gets tentative FDA nod

Supernus (Nasdaq: SUPN) epilepsy drug gets tentative FDA nodPalm Beach, FL 6/26/12 (StreetBeat) -- Supernus Pharmaceuticals Inc (Nasdaq: SUPN) said the U.S. health regulator granted a tentative approval to its epilepsy treatment Trokendi XR, sending its shares up 38 percent before the bell.

The company said the U.S. Food and Drug Administration completed a review of Trokendi, an extended release version of Johnson & Johnson's widely-used epilepsy drug Topamax, and did not seek any additional clinical trials.

Topamax is off patent protection and is available generically.

Supernus said the final approval of its drug depended on resolving a marketing exclusivity issue raised by the FDA regarding a specific pediatric population.

Shares of Supernus were trading at $7.75 in premarket trade. They closed at $5.71 on Monday on the Nasdaq.

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