DiagnosticsPharmalucence, Inc. Announces FDA Approval For Its Generic Sestamibi Kit
Pharmalucence, Inc., a leading supplier of radiopharmaceutical products, announced that it received approval from the U. S. Food and Drug Administration (FDA) Office of Generic Drugs for its Abbreviated New Drug Application (ANDA) 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® 1, an imaging agent used in evaluating myocardial function and 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.
Glenn Alto, President and CEO of Pharmalucence said, "When Pharmalucence was formed two years ago we committed to bring choice to the nuclear medicine community through an expanded line of radiopharmaceutical kits. The approval of our sestamibi kit marks the second generic imaging agent to emerge from the Pharmalucence Development team. Pharmalucence remains focused on delivering the products and enhancing the manufacturing assets that will provide nuclear medicine practitioners high quality imaging agents now and in the future."
Pharmalucence will begin shipping their generic sestamibi kit on August 3.
1. Cardiolite® is a trademark of Lantheus Medical Imaging, Inc.
Pharmalucence, Inc.