Supernus Pharmaceuticals has received approval from the FDA for Oxtellar XR, a novel once-daily extended-release formulation of oxcarbazepine (formerly known as SPN-804).
The approval letter states that the FDA has completed its review of the application and that Oxtellar XR is approved effective 19th October 2012 for use as recommended in the agreed-upon labelling. The FDA granted a waiver for the paediatric study requirement for ages birth to one month and a deferral for submission of post-marketing assessments for children one month to six years of age. The post-marketing pharmacokinetic assessments are due in 2016, followed by clinical assessments in 2021. Supernus anticipates launching Oxtellar XR in the first quarter of 2013.
Oxtellar XR is an antiepileptic drug indicated for adjunctive therapy in the treatment of partial seizures in adults and in children six to 17 years of age.