Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Supernus Pharmaceuticals Obtains Final Approval From FDA For Trokendi XR

RELATED NEWS
Trade SUPN now with 

Supernus Pharmaceuticals Inc. (SUPN: Quote) said Monday that it received final approval from the Food & Drug Administration or the "FDA" for Trokendi XR, a novel once-daily extended release formulation of topiramate for the treatment of epilepsy. The company noted that it expects to launch the product and for it to be available in pharmacies over the next few weeks.

The company stated that the FDA granted a waiver for certain pediatric study requirements and a deferral for submission of post-marketing pediatric pharmacokinetic assessments that are due in 2019 followed by clinical assessments in 2025.

Trokendi XR is an antiepileptic drug indicated for initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures, and adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome.

The company noted that the product will be available in 25mg, 50mg, 100mg and 200mg extended-release capsules.

Click here to receive FREE breaking news email alerts for Supernus Pharmaceuticals, Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Europe's passenger car registrations continued to rise in August, pursuing the upward trend commenced twelve months ago, the European Automobile Manufacturers Association reported Wednesday. Car sales increased 2.1 percent in August and 5.6 percent in July. Overall, 688,464 new cars were registered... Stocks moved notably higher over the course of the trading day on Tuesday after recovering from an initial move to the downside. With the strong upward move on the day, the Dow reached a new record intraday high before giving back some ground. President Barack Obama is scheduled to travel to the headquarters of the Centers for Disease Control and Prevention in Atlanta, Georgia, on Tuesday to outline steps the U.S. will take to help combat the Ebola outbreak in West Africa.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.