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news.The US Food and Drug Administration (FDA) has granted tentative approval to Supernus Pharmaceuticals' Supplemental New Drug Application (sNDA) requesting a label expansion for Trokendi XR to include prophylaxis of migraine headache in adults.
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The approval of the sNDA is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but is subject to the pediatric exclusivity which expires March 28, 2017. Final approval may not be made effective until this exclusivity period has expired.
In addition, the Company announced today that the FDA has granted final approval to expand the label for Trokendi XR for monotherapy treatment of partial onset seizures to include adults and pediatric patients 6 years and older, rather than 10 years and older.
"We will continue to work with the FDA to gain final approval upon the expiration of pediatric exclusivity," stated Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals.
"We are prepared and ready to launch the migraine indication upon receiving full FDA approval."
About Trokendi XR
Trokendi XR is the first approved novel once-daily extended release formulation of topiramate for the treatment of epilepsy. Trokendi XR is an antiepileptic drug indicated for initial monotherapy in patients 6 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 product is available in 25mg, 50mg, 100mg and 200mg extended-release capsules.