Supernus Pharmaceuticals Inc (SUPN)

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7:30AM Supernus Pharma announces final FDA approval and upcoming launch of Trokendi (SUPN) 6.64 : CO received final approval from the FDA or Trokendi XR, a novel once-daily extended release formulation of topiramate for the treatment of epilepsy. The company expects to launch the product and for it to be available in pharmacies over the next few weeks. The approval letter states that the FDA has completed its review of the application and that Trokendi XR is approved effective August 16, 2013 for use as recommended in the agreed-upon labeling. The FDA granted a waiver for certain pediatric study requirements and a deferral for submission of post-marketing pediatric pharmacokinetic assessments that are due in 2019 followed by clinical assessments in 2025.