Supernus Pharmaceuticals,Inc. (NASDAQ:SUPN) Files An 8-K Other Events

ME Staff 8-k
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Supernus Pharmaceuticals,Inc. (NASDAQ:SUPN) Files An 8-K Other Events
Item 8.01 Other Events

On April 5, 2017, Supernus Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the Food and Drug Administration granted final approval to the Company’s Supplemental New Drug Applications (“sNDAs”) requesting a label expansion for Trokendi XR® to include prophylaxis of migraine headache in adults and adolescents 12 years and older. The Company was granted tentative approval of one of the two sNDAs in August 2016, with final approval subject to the pediatric exclusivity of the innovator’s drug in the adolescent population, which expired March 28, 2017.

A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

The following document is furnished as an Exhibit  to Item 8.01 hereof:

Exhibit 99.1 — Press Release Dated April 5, 2017.


About Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN)

Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases. The Company offers Oxtellar XR (extended-release oxcarbazepine) and Trokendi XR (extended-release topiramate), its two treatments for patients with epilepsy. In addition, it is developing multiple product candidates in psychiatry to address unmet medical needs and market opportunities for the treatment of impulsive aggression (IA) and for the treatment of attention deficit hyperactivity disorder (ADHD). It is developing SPN-810 (molindone hydrochloride) to treat IA in patients having ADHD. It is developing SPN-812 (viloxazine hydrochloride) as a candidate to treat patients having ADHD. The Company’s neurology portfolio consists of Oxtellar XR and Trokendi XR, which are the first once-daily extended release oxcarbazepine and topiramate products, respectively, indicated for epilepsy in the United States market.

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) Recent Trading Information

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) closed its last trading session down -0.12 at 31.17 with 320,282 shares trading hands.