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
Delta Airlines becomes the latest airline to experience pet transport disaster. An 8-week-old puppy was flown across the country to the wrong airports by Delta Airlines landing in Detroit, Las Vegas and Salt Lake City before finally making to Idaho. On Saturday, a breeder put Josh Schlaich's new,... Facebook stock is plunging due to self-inflicted wounds. What was once America's favorite social media site is being a accused of turning into a cesspool of misinformation and narcissism. Facebook Inc.'s security chief, Alex Stamos, plans to step down from the company amid questions over Russia's... Media company Tronc, Inc. said Monday that Michael Ferro has stepped down as chairman of its board of directors. The company named Chief Executive Justin Dearborn as chairman of the board. Tronc noted that Ferro, its largest shareholder, is retiring from the board as the company prepares to close on the $500 million sale of its flagship newspaper, the Los Angeles Times, to local ownership.
comments powered by Disqus
Follow RTT