DraxImage gets FDA OK for skeletal imaging kit

Radiopharmaceutical provider DraxImage has received Food and Drug Administration approval to produce and market a new formulation to prepare a skeletal imaging agent used to demonstrate areas of altered osteogenesis, or bone growth.

Called MDP-25, the kit is a preparation for technetium Tc-99m medronate injection, which is used in applications ranging from metastatic bone disease, Paget’s disease, arthritic disease, and osteomyelitis, according to the Mississauga, Ontario-based firm. Each vial of MDP-25 contains freeze-dried powder that is reconstituted immediately before use with radioactive sodium pertechnetate solution.

The resulting active labeling agent remains stable throughout the 12-hour life of the preparation, and following injection the agent is accumulated and retained by the skeleton for imaging by a gamma camera. DraxImage said it expects to make the MDP-25 imaging kit available through the company and its distribution network during the second quarter.

By AuntMinnie.com staff writers
March 1, 2004

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