Pharmalucence, Inc. Announces FDA Approval for its Generic Sestamibi Kit
Published: Jul 20, 2009
BEDFORD, Mass.--(BUSINESS WIRE)--Pharmalucence, Inc., a leading supplier of radiopharmaceutical products, announced today 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.