- For Print
- June 27, 2017
Ʊ., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Ʊ”) announced today that, in alignment with Chinese regulations, it has temporarily withdrawn its new drug application for anticancer agent eribulin mesylate (Brand name: Halaven®) in China in order to submit additional documentation.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, Ʊ submitted a new drug application for Halaven seeking approval as a treatment for locally advanced or metastatic breast cancer. Ʊ 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.