Hospira Japan Receives Approval for New Indication for 'Precedex IVâ„¢ 200ug'
OSAKA, Japan, Aug. 22 /PRNewswire-FirstCall/ -- Hospira Japan Co., Ltd. today announced it has received an approval for the long-term (greater than 24 hour) use of the sedative "Precedex IV™200ug" (generic name: dexmedetomidine hydrochloride). This approval follows Hospira's first launches earlier this year of Precedex in Canada and in South Korea, important milestones for Hospira as the company continues to build the molecule's global presence.
Originally, Precedex was approved in Japan in 2004 for sedation of initially intubated and mechanically ventilated patients in the intensive care setting for use up to 24 hours. However, some clinicians specializing in this area were interested in utilizing the product for patients who require greater-than-24-hour sedation.
In response to the clinician interest, Hospira Japan started a series of consultations with the Pharmaceuticals and Medical Devices Agency Japan (PMDA) for the planning of a long-term administration study. As a result of the positive outcome of the study, Japan, one of the largest pharmaceutical markets in the world, became the first market in the Asia-Pacific region to receive approval of over 24-hour usage of Precedex.
"This approval from the Ministry of Health, Labour and Welfare (MHLW) makes Precedex available to a greater number of patients, providing a new sedative tool for patients who are critically ill and require sedation of greater than 24 hours for safety and comfort," said Sumant Ramachandra, M.D., Ph.D., senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. "Our clinical research and development further demonstrates Hospira's commitment to patient safety and improved clinical outcomes."
The clinical study in Japan evaluated safety and efficacy of Precedex long-term administration on patients in the intensive care setting. The study achieved its primary efficacy endpoint: time the pa