Supernus Announces FDA Approval of sNDA to Expand Oxtellar XR® Label to Include Monotherapy
“We are pleased with the timely approval of the expanded indication for Oxtellar XR. We look forward to launching Oxtellar XR in the first quarter 2019 as a new monotherapy treatment option for partial-onset seizures. We believe that expanding the indication to include monotherapy represents an additional growth opportunity for Oxtellar XR,” said
About Oxtellar XR®
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 150mg, 300mg, and 600mg extended-release tablets.
For full prescribing and safety information https://oxtellarxr.com/assets/OxtellarXRPrescribingInformation.pdf
Forward Looking Statements
This press release contains forward-looking statements regarding the timing of the Company’s ability to market Oxtellar XR® for monotherapy treatment in epilepsy. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, the Company's ability to 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 set forth from time to time in the Company’s
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Source: Supernus Pharmaceuticals, Inc.