logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Tentatively Approves Supernus Pharma's Epilepsy Drug Supernus

Supernus Pharmaceuticals, Inc (SUPN), a developer of products to treat central nervous system, Monday said it received a tentative approval letter from the Food & Drug Administration or FDA for its epilepsy drug Trokendi XR. The product is tentatively approved for use as recommended in the submitted and agreed-upon labeling. Trokendi XR formerly known as SPN-538 is a novel once-daily extended release formulation of topiramate.

"We will now submit the "Request for Final Approval" letter to the FDA based on which we expect to receive Final Approval and then launch our product, as anticipated, in the third quarter of 2013," said Jack Khattar, chief executive officer.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Lab equipment maker Thermo Fisher Scientific Inc. has agreed to acquire electron microscope maker FEI Co. for about $4.2 billion in cash, the two companies said Friday. Thermo Fisher noted that FEI's electron microscopy platform will complement its own mass spectrometry systems to accelerate advancements in structural biology. While reporting a wider loss for the first quarter, Sears Holdings Corp. said it has decided to "aggressively evaluate" all potential alternatives for its top brands - Kenmore, Craftsman and DieHard or KCD, and the Sears Home Services or SHS businesses. Sears has retained Citigroup Global Markets and LionTree Advisors to assist in its efforts. Philips Lighting, the splinter group of Dutch consumer electronics giant Philips, saw its shares rally around 8.50 percent on its debut on Friday at the Amsterdam stock exchange. The shares are currently at 21.70 euros, above its set pricing of 20 euros per share.
comments powered by Disqus
Follow RTT