Canadian radiopharmaceutical firm DraxImage of Kirkland, Quebec, has received U.S. Food and Drug Administration (FDA) approval for its generic sestamibi offering.
The product was found to be bioequivalent and therapeutically equivalent to Cardiolite from Lantheus Medical Imaging of North Billerica, MA, according to DraxImage parent Jubilant Organosys of Noida, India. The kit is used in the preparation of technetium-99m sestamibi injection, a myocardial perfusion cardiac imaging agent.
GE Healthcare of Chalfont St. Giles, U.K., has inked an exclusive distribution agreement to sell the generic sestamibi product in the U.S. through its nuclear pharmacy network.
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