logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Tentatively Approves Supernus Pharma's Epilepsy Drug Supernus

Supernus Pharmaceuticals, Inc (SUPN: Quote), 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

Editors Pick
American Airlines Group said pilots at its subsidiaries American Airlines and US Airways, represented by Allied Pilots Association, have approved a new five-year contract which provides immediate pay raises of 23 percent and subsequent annual raises of three percent for the next five years. LEGO Group, TT Games and Warner Bros. Interactive Entertainment have announced their 2015 slate of video games, including LEGO Jurassic World, LEGO Marvel's Avengers, and as well as new hand-held and mobile titles. Social-networking giant Facebook, Inc. is said to be testing their new 'Place Tips' feature for iOS users that will rival a similar service being provided by Yelp or Foursquare. The feature will provide the user relevant content about their location as long as they are there through pop ups on their news feed page of Facebook.
comments powered by Disqus
RELATED NEWS
Trade SUPN now with 
Follow RTT