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news.Eisai has resubmitted the New Drug Application (NDA) to the US FDA for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy.
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According to the company, the FDA will determine acceptance of filing within 60 days of submission.
The application was originally submitted in May 2011, to which FDA issued a Refusal to File letter in July 2011 requesting reformatting and reanalyses of some datasets in the dossier.
Eisai intends to address the issue of epilepsy as part of their corporate human health care (hhc) mission.