Eisai temporarily withdraws cancer drug NDA in China
Japanese drug major Eisai (TYO: 4523) has said that, in alignment with Chinese regulations, it has temporarily withdrawn its new drug application for its anticancer agent Halaven (eribulin mesylate) in China.
The decision was made in order to submit additional documentation. No additional clinical trials have been scheduled, and resubmission will take place as soon as the additional documentation is prepared.
In July 2016, Eisai submitted a new drug application for Halaven seeking approval as a treatment for locally advanced or metastatic breast cancer. Eisai is working closely with the regulatory authority in China for resubmission of this application as quickly as possible in order to contribute to breast cancer patients and their families in China.
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