Eisai Temporarily Withdraws New Drug Application for Anticancer Agent Halaven in China
2017年6月27日 - 7:54PM
JCN Newswire (英)
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regulations, it has temporarily withdrawn its new drug application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.
About Eisai
Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human
health care (hhc) company that discovers, develops and markets
products throughout the world. Eisai focuses its efforts in three
therapeutic areas: integrative neuroscience, including neurology
and psychiatric medicines; integrative oncology, which encompasses
oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of
research facilities, manufacturing sites and marketing
subsidiaries, Eisai actively participates in all aspects of the
worldwide healthcare system. For more information about Eisai Co.,
Ltd., please visit www.eisai.com.
Source: Eisai
Contact:
Public Relations Department,
Eisai Co., Ltd.
+81-3-3817-5120
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