Supernus Announces Final FDA Approval and Upcoming Launch of Trokendi XR(TM)
The approval letter states that the
"We are very excited about the approval of Trokendi XR and its upcoming launch. This is excellent news for Supernus, its shareholders, and patients with epilepsy. We remain committed to the epilepsy community and very much look forward to now having two products, Trokendi XR and Oxtellar XR, available to patients," said
About Trokendi XR™
Trokendi XR is a novel once- daily extended release formulation of topiramate. Trokendi XR is an antiepileptic drug (AED) indicated for initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years of age and older with partial onset or primary generalized tonic-clonic seizures, and adjunctive therapy in patients 6 years of age and older with seizures associated with Lennox-Gastaut syndrome. The product will be available in 25mg, 50mg, 100mg and 200mg extended-release capsules.
For full prescribing and safety information, click here.
Forward Looking Statements
This press release contains forward-looking statements regarding the potential for Trokendi XR to treat epilepsy, and the timing of the product's 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 commercialize the product successfully, whether physicians will prescribe and patients will use the product, once available, and competition in the market. For a further description of these and other risks facing the Company, please see the risk factors described in the Company's Annual Report Form 10-K 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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