Approval in Japan for Precedex for sedation and tests in non inturbated children
The Japanese health ministry on February 24 approved label expansions for a batch of medicines including a pediatric indication for Pfizer’s sedative agent Precedex (dexmedetomidine)
An 2 agonist, Precedex is now approved for sedation during non-invasive procedures and tests in non-intubated children. The drug has been designated as Japan’s first “drug for specific use” for this pediatric indication.
The label expansion of the drug was initially put up for the ministry’s advisory panel review in October, but members put their decision on hold with opinions raised around safety measures. The panel later endorsed its approval in January after it was decided that appropriate warnings will be made through promotional materials and notices from relevant academic societies to ensure its safe use.
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