eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced the u.s. food and drug administration (fda) has accepted for review the supplemental new drug application (snda) for eisai‘s antiepileptic drug (aed) fycompa®(perampanel). this application seeks approval for an indication expansion to cover pediatric patients with partial onset seizures and primary generalized tonic-clonic seizures (pgtc) seizures. furthermore, eisai has included a study in this snda requested by the fda in a pediatric written request, and therefore fda has designated this application for priority review, which means the review period will be six months. the fda has assigned a prescription drug user fee act (pdufa) action date of september 28, 2018.
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