Pharmalucence gets FDA OK for Sestamibi kit

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Pharmalucence, a supplier of radiopharmaceutical products, has received approval from the FDA's Office of Generic Drugs for its abbreviated new drug application to manufacture and market its kit for the preparation of technetium Tc-99m Sestamibi injection.

The FDA has determined that Pharmalucence's Sestamibi Kit is therapeutically equivalent to Cardiolite--manufactured and marketed by Lantheus Medical Imaging--an imaging agent used to detect coronary artery disease by localizing myocardial ischemia and infarction.

The agent is also for use in breast imaging as a second-line diagnostic after mammography to assist in the evaluation of breast lesions, according to the Bedford, Mass.-based Pharmalucence.