FDA clears Draximage's skeletal imaging agent

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Draximage Inc. has received approval from the FDA to produce and market a new formulation of a diagnostic product -- called MDP-25 -- for preparing a skeletal imaging agent used to demonstrate areas of altered osteogenesis or bone growth.

MDP-25 would be used in metastatic bone disease, such as Paget's disease, arthritic disease and osteomyelitis, as it provides an increased ability to more effectively image the extremities of the skeleton, particularly hands and feet.

MDP-25 is a kit for the preparation of Technetium Tc 99m Medronate Injection (99m Tc-Methylene Diphosphonic Acid Kit). Each vial of MDP-25 contains freeze-dried (lyophilized) 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.

Following injection, the agent is accumulated and retained by the skeleton so that a gamma camera can be used to obtain an image of the patient's skeleton. Areas of abnormal osteogenesis show altered uptake making it possible to visualize a variety of bone lesions.

Draximage, a division of Draxis Health Inc., expects to begin distribution of MDP-25 in the second quarter.