Radiopharmaceutical product supplier Pharmalucence has received U.S. Food and Drug Administration (FDA) approval to manufacture and market its kit for preparing technetium-99m (Tc-99m) sestamibi injection.
The FDA determined that the kit is equivalent to the Cardiolite myocardial perfusion radiopharmaceutical from Lantheus Medical Imaging of North Billerica, MA, according to Pharmalucence of Bedford, MA. In addition, the agent is also suitable in breast imaging as a second-line diagnostic tool for evaluating breast lesions.
Pharmalucence plans to begin generic sestamibi shipments on August 3.
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