The approval letter states that the
"This is excellent news for Supernus and patients with epilepsy. 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
"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. I would like to take this opportunity to thank all Supernus employees for a remarkable achievement in developing and advancing two NDAs in a relatively short period of time by industry standards. Also, I would like to thank our advisors and clinical investigators for their assistance in completing the clinical development of Oxtellar XR. The approval of Oxtellar XR adds to our proven and long track record of developing novel and differentiated products using our technologies and expertise," added
About Oxtellar XR™
Formerly known as SPN-804, Oxtellar XR is a novel once- daily extended release formulation of oxcarbazepine. 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.
For full prescribing and safety information, click here.
Forward Looking Statements
This press release contains forward-looking statements regarding the potential for Trokendi XR and Oxtellar XR to treat epilepsy, their approval, and the timing of their availability to physicians. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, risks regarding the company's ability to obtain final approval for its products, commercialize its products successfully, whether physicians will prescribe and patients will use its products, once available, and competition in their respective markets. For a further description of these and other risks facing the company, please see the risk factors described in the company's Registration Statement on Form S-1 that was filed with the
Jack Khattar, President & CEO Gregory S. Patrick, Vice President and CFO Supernus Pharmaceuticals, Inc.Tel: (301) 838-2591
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