Eisai Inc. announced today that it resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the U.S. Food and Drug Administration (FDA) on December 22, 2011. 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.
Eisai defines epilepsy as a therapeutic area of focus. By offering multiple treatment options, Eisai seeks to make further contributions to help address the diversified needs of epilepsy patients and their families as part of our corporate human health care (hhc) mission.
Source Eisai Inc.