DraxImage, the radiopharmaceutical division of Mississauga, Ontario-based Draxis Health, has filed for marketing clearance for its DraxImage Sestamibi with European regulatory authorities. DraxImage Sestamibi is a generic kit for the preparation of technetium-99m labeled (Tc-99m) sestamibi, an intravenous imaging agent used in myocardial perfusion imaging to evaluate cardiac blood flow.
The contrast agent is the most widely used radiopharmaceutical product in the nuclear medicine market segment, according to the Montreal-based DraxImage.
The U.S. Food and Drug Administration recently acknowledged receipt and acceptance for review of the Abbreviated New Drug Application (ANDA) for DraxImage Sestamibi that was submitted to the FDA earlier this year.
In addition to seeking regulatory clearance for the compound in Europe and the U.S., the Canadian firm said that it is actively pursuing marketing and distribution partnerships for its sestamibi preparation in Europe and in North America.