logo
Share SHARE
FONT-SIZE Plus   Neg

Supernus Pharmaceuticals Obtains Final Approval From FDA For Trokendi XR

Supernus Pharmaceuticals Inc. (SUPN) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Electric car maker Tesla Motors Inc. (TSLA), Wednesday reported a loss for the fourth quarter that was narrower than last year. The company said it expects to start volume production of Model 3 by September. Palo Alto, California-based Tesla reported fourth-quarter loss of $121.3 million or $0.78... Canada based Maple Leaf Foods Inc. Wednesday said it has reached a definitive agreement with Brynwood Partner VI L.P. for the acquisition of Lightlife Foods Inc. The deal would be worth $140 million plus other costs. Light is a brand in U.S. for refrigerated plant based protein foods. A hedge fund is an alternative investment fund that uses pooled funds from accredited individuals or institutional investors and invests these funds in different assets with a goal of generating high returns. Hedge funds are generally accessible only to accredited or qualified investors. They cannot...
comments powered by Disqus
Follow RTT