Canadian radiopharmaceutical firm DraxImage has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for its generic kit for the preparation of technetium-99m (Tc-99m) sestamibi.
Tc-99m sestamibi is a nuclear medicine imaging agent used in myocardial perfusion imaging (MPI). Once its ANDA is approved, the Kirkland, Quebec-based developer said it plans to enter the MPI market after the key patent for the currently marketed Tc-99m sestamibi product expires, which is expected to be in 2008 for the U.S. The firm said it also plans to file for marketing approvals in other jurisdictions, including European countries.
Tc-99m sestamibi is currently marketed under the trade name Cardiolite by Bristol-Myers Squibb Medical Imaging of North Billerica, MA.
By AuntMinnie.com staff writers
February 2, 2007
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