Mitsubishi Tanabe Pharma Corporation Provides U.S. Regulatory Update on ND0612
Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative Director: Akihiro Tsujimura; hereinafter, “MTPC”), a member of the Mitsubishi Chemical Group, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (hereinafter "CRL") for the New Drug Application (NDA) of investigational ND0612 for the treatment of motor fluctuations in people with Parkinson’s disease which is being developed by its wholly owned subsidiary, NeuroDerm Ltd. (Head Office: Rehovot, Israel; CEO: Kengo Isshiki).
MTPC Group is currently reviewing the CRL and will work closely with the FDA to address its comments to consider the future direction.
*A Complete Response Letter is issued by the FDA upon completion of the review for the new drug application when the application is not approved under the current conditions.
