FDA Accepts Eisai's Resubmission of Perampanel NDA

The FDA has accepted for review Eisai's resubmission of the New Drug Application for perampanel, an investigational drug for the treatment of partial-onset seizures associated with epilepsy.

Eisai Inc. announced Monday that the U.S. FDA has accepted for review Eisai's resubmission of the New Drug Application (NDA) for perampanel (E2007).

The investigational drug is for the treatment of partial-onset seizures associated with epilepsy.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of October 22, 2012.

Acceptance of the NDA indicates that the FDA has found the company's resubmission to be sufficiently complete to review. The original NDA was submitted to the FDA on May 25, 2011 and the FDA issued a Refuse to File letter on July 29, 2011. The NDA was resubmitted on December 22, 2011.

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