(By Balaseshan) Supernus Pharmaceuticals Inc. (NASDAQ: SUPN) said it has received approval from the U.S. Food & Drug Administration (FDA) for Oxtellar XR , a once-daily extended release formulation of oxcarbazepine (formerly known as SPN-804) to treat epilepsy.
The FDA has completed its review of the application and that Oxtellar XR is approved effective October 19 for use as recommended in the agreed-upon labeling.
The FDA granted a waiver for the pediatric study requirement for ages birth to one month and a deferral for submission of post-marketing assessments for children 1 month to 6 years of age. The post-marketing pharmacokinetic assessments are due in 2016 followed by clinical assessments in 2021.
"We are very excited for having obtained two NDA approvals since our IPO in May of 2012; tentative approval on Trokendi XR 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, " said Jack Khattar, Chief Executive of Supernus.
The company said it will now focus on completing the build-out of its commercial organization including, hiring, training and deploying field sales force to launch Oxtellar XR in the first quarter of 2013.
Oxtellar XR is an antiepileptic drug (AED) indicated for adjunctive therapy in the treatment of partial seizures in adults and in children 6 to 17 years of age.
The recommended daily dose for adults is 1200 mg to 2400 mg once per day, and for children 6 to 17 years of age is 900mg to 1800mg depending on weight. The product will be available in 150mg, 300mg and 600 mg extended-release tablets.
SUPN closed Friday's regular session up 1.09% at $12.97. The stock has been trading between $4.30 and $16.68 for the past 52 weeks.