Tuesday, December 27, 2011
Eisai has resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the FDA. This resubmission comes after the FDA issued a Refusal to File letter in July 2011 in which FDA requested reformatting and reanalyses of some datasets in the dossier. The application was originally submitted in May 2011.
The FDA will determine acceptance of filing within 60 days of submission.