Drug news
Trokendi XR (topiramate extended release) sNDA filed with FDA for prophylaxis of migraine headache- Supernus Pharmaceuticals
The FDA has accepted for review the supplemental new drug application (sNDA) for Trokendi XR (topiramate extended release), from Supernus Pharmaceuticals, requesting FDA approval to expand the indication for Trokendi XR beyond the current indication for the treatment of epilepsy to include treatment for adults for prophylaxis of migraine headache. Under the Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has set a target date in the second quarter of 2016 to complete its review.
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