Printer Friendly

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.

Copyright [c] 2006 Japan Corporate News Network. All rights reserved.
COPYRIGHT 2006 Japan Corporate News Network K.K.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

Article Details
Printer friendly Cite/link Email Feedback
Publication:JCNN News Summaries
Date:Oct 2, 2006
Words:163
Previous Article:NICT to Launch the World's Fastest and Highest Density Optical Modulator.
Next Article:IIJ Establishes New Subsidiary Net Chart Japan Inc.
Topics:


Related Articles
Sankyo Announces Completion of Subject Registration for ORIENT Clinical Trial.
Daiichi Pharmaceutical and Celestar Lexico-Sciences Completes Joint Research on Genome Drug.
Sankyo Pharma GmbH to Transfer 11 Items to STADA Arzneimittel.
Daiichi Wins Lawsuit Against Mylan Pharmaceuticals Regarding Patents for Levofloxacin.
Sankyo Licenses Cardiovascular Disease Drug Candidate KAI-9803 from KAI Pharmaceuticals.
Daiichi Sankyo Now Authorized to Market Its Products in China.
Sankyo to Manufacture, Distribute Olmetic Antihypertensive Drug in China.
Fujifilm Acquires Daiichi Radioisotope Laboratories, Diagnostic Radiopharmaceuticals Manufacturer.
Daiichi Pharmaceutical Korea to Become Wholly Owned Subsidiary of Daiichi Pharmaceutical.
Sanko Lifetech Transfers Animal Health Products Business to Novartis Animal Health.

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters