Supernus Pharmaceuticals,
Inc. SUPN, a specialty pharmaceutical company, received final
approval from the Food & Drug Administration (the "FDA") for 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.
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