Hospira gains new indication for Precedex in Japan; announces succession plan for CEO and COO

24 August 2010

The Japanese subsidiary of US specialty pharmaceutical and drug delivery firm Hospira has received approval for the long-term (greater than 24 hour) use of the sedative Precedex IV (dexmedetomidine hydrochloride) 200ug. This approval follows the first launches earlier this year of Precedex in Canada and in South Korea, important milestones as the company continues to build the molecule's global presence, said Hospira.

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 country in the Asia-Pacific region to receive approval of over 24-hour usage of Precedex.

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