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July 31, 2011

FDA Rejects Eisai Epilepsy Drug

Japanese drug maker Eisai has received a refusal to file letter for perampanel, a drug intended to treat epilepsy. The US Food and Drug Administration (FDA) turned down the drug application and requested reformatting and re-analysis of some datasets to assist with a substantive review,

By cms admin

Japanese drug maker Eisai has received a refusal to file letter for perampanel, a drug intended to treat epilepsy.

The US Food and Drug Administration (FDA) turned down the drug application and requested reformatting and re-analysis of some datasets to assist with a substantive review, Eisai said in a statement, adding that it believes that no new non-clinical or clinical studies are required to support this filing.

Eisai also said that the refusal letter does not comment on the approvability of the drug, and no determination has been made with regard to its efficacy or safety.

The drug was submitted for approval in May this year and has been developed to treat partial-onset seizures associated with epilepsy.

Eisai said it will work closely with the regulator to provide the information requested for resubmission of its application “as quickly as possible” in order to contribute to epilepsy patients and their families.

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