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
Dutch consumer electronics giant Philips Electronics NV reported Monday lower attributable net income in its third quarter, while pre-tax income increased. Sales were flat on a reported basis, but grew 4 percent on a comparable basis mainly on growth in China. Further, the company said its outlook for 2017 remains unchanged despite ongoing global uncertainties. 10 Worst Places To Raise A Family Whether you are a young couple building a nest or seasoned parents looking for a change of scenery, there are number of places around the country that should be avoided, according to personal finance website WalletHub. They looked at mainly five categories for... A passenger has filed a lawsuit against Canadian budget airline Sunwing Airlines for serving him cheap sparkling wine instead of champagne on board a flight, according to media reports. The Canadian passenger, Daniel MacDuff, reportedly boarded his Sunwing flight to Cuba in February, on a flight package that advertised a complimentary on-board champagne toast.
comments powered by Disqus
Follow RTT