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
Mortgage rates dropped this week to the lowest level in more than three years hurt by the UK's shocking decision to exit European Union. Releasing the results of its primary mortgage market survey, Freddie Mac said that the 30-year fixed-rate mortgage or FRM averaged 3.48 percent for the week ended... Walt Disney Co. (DIS) have installed new signs and temporary barriers across it parks and resorts warning against alligators. References, jokes and appearances of crocodiles eating children have also been cut. Walt Disney World made these changes after the death of 2-year old Lane Graves, who was... HSBC, the largest bank in the UK, has announced that it will not will relocate its headquarters out of London despite the shocking decision by the UK to leave the European Union. HSBC Chairman Douglas Flint, chairman, speaking at a conference in London, said that HSBC would stick to its plan to keep...
comments powered by Disqus
Follow RTT