Eisai Temporarily Withdraws New Drug Application for Anticancer Agent Halaven in China

Jun 27, 2017 19:54 JST

Source: Eisai

Plans to Resubmit Application After Preparing Additional Documentation

TOKYO, Jun 27, 2017 - (JCN Newswire) - Eisai Co., Ltd. announced today that, in alignment with Chinese regulations, it has temporarily withdrawn its new drug application for anticancer agent eribulin mesylate (Brand name: Halaven) in China in order to submit additional documentation.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.

Contact:

Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120

Source: Eisai
Sectors: BioTech

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