Posted by Michael Wonder on 15 Dec 2018
Supernus announces FDA approval of sNDA to expand Oxtellar XR label to include monotherapy
14 December 2018 - Supernus Pharmaceuticals announced today that the United States FDA has approved the Company’s supplemental new drug application for Oxtellar XR.
The application requested FDA approval to expand the indication for Oxtellar XR beyond the current indication of adjunctive therapy in the treatment of partial-onset seizures in adults and in children 6 to 17 years of age.
Oxtellar XR is the first approved novel, oral once-daily extended release formulation of oxcarbazepine for the treatment of partial-onset seizures in patients 6 years of age and older. The product is available in 150 mg, 300 mg and 600 mg extended-release tablets.
