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Daiichi Sankyo Subsidiary Applies for Additional Indication for Fentanyl Injection.

Tokyo, Japan, Oct 2, 2006 - (JCN) - Sankyo Co., Ltd., a wholly owned subsidiary of Daiichi Sankyo Company, Limited, has filed an application for an additional indication for Fentanyl Injection 0.1 mg and 0.25 mg (generic name: fentanyl citrate) with the Ministry of Health, Labour and Welfare.

Fentanyl Injection is widely used in analgesia and sedation, as well as in anesthesia and as an anesthetic adjunct, but its use has been contraindicated in Japan for pediatric patients aged two and under because its safety in this group had not been established. However, driven by a need in this area, a physician-led Phase III trial was conducted in pediatric patients. The trial, which included newborns and infants, generated valuable information about a patient group that is generally excluded from surgical clinical studies.

On the basis of the results, Sankyo filed for the additional indication in pediatric patients, including infants aged two and under.

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Publication:JCNN News Summaries
Date:Oct 2, 2006
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