Additional indications in Japan for Diagnogreen and Sawacillin
Japanese drug major Daiichi Sankyo (TYO: 4568) says it has received approval in Japan for a supplemental New Drug Application (sNDA) for an additional indication of Diagnogreen (indocyanine green, ICG) 25mg intravenous injection for near-infrared fluorescence angiography during cerebrovascular surgery.
A preliminary evaluation was conducted on July 29, 2011, at the meeting of the First Committee on New Drugs of the Pharmaceutical Affairs and Food Sanitation Council, and the application1) was permitted, leading Daiichi Sankyo to submit the sNDA for an additional indication of Diagnogreen in August.
This indication is based on the fluorescence property of ICG in blood when illuminated by near-infrared light. ICG has been recently used for the real-time assessment of cerebral blood flow during cerebrovascular surgery, and is approved for this indication in European countries including the UK and Germany.
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