Supernus Pharmaceuticals has received approval from the FDA for its Oxtellar XR, a new once-daily extended release formulation of oxcarbazepine.
Oxtellar XR is an antiepileptic drug used as an adjunct therapy to treat partial seizures in adults and in children 6 to 17 years of age.
Supernus chief executive officer, president and director Jack said Supernus is excited to obtain two NDA approvals since IPO in May of 2012; tentative approval on Trokendi XR(TM) received in June and now final approval on Oxtellar XR.
''We are committed to the epilepsy community and very much look forward to making our products available to patients," Khattar added.
"This approval represents a significant milestone for Supernus in realizing its vision of becoming a leading CNS specialty pharmaceutical company.
''We will now focus on completing the build-out of our commercial organization including, hiring, training and deploying our field sales force to launch Oxtellar XR in the first quarter of 2013.''
