FDA grants final approval for Trokendi XR for Epilepsy
The FDA has issued final approval for Epilepsy drug Trokendi XR (topiramate) from Supernus Pharmaceuticals. It granted a waiver for certain paediatric study requirements and a deferral for submission of post-marketing paediatric pharmacokinetic assessments that are due in 2019, followed by clinical assessments in 2025.
The extended release drug was tentatively approved in June 2012, depending on resolving a marketing exclusivity issue raised by the FDA regarding a specific pediatric population. Trokendi ER is an extended release version of Johnson & Johnson's widely used Epilepsy drug Topamax which is also marketed in generic formulations.
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