It is currently approved for use with the GalliaPharm® Ga 68 generator from Eckert & Ziegler. An orphan drug is defined as a drug that treat diseases or conditions that affect 200,000 or fewer individuals in the United States or 5 out of 100,000 in the European Union.Īdvanced Accelerator Applications has announced that NETSPOT will be supplied in the United States by Cardinal Health of Dublin, OH, a healthcare services company operating the largest radiopharmaceutical network in the nation. Gallium 68Ga-Dotatate received Orphan Drug Designation in March 2014 from both the FDA and the European Medicines Agency. The uptake of 68Ga-Dotatate reflects the level of somatostatin receptor density in neuroendocrine tumors. 68Ga-Dotatate, a positron emitting analogue of somatostatin, works by binding to such receptors. Neuroendocrine tumors have receptors for somatostatin, a hormone that regulates the endocrine system. The tumors develop in the hormone-producing cells of the body’s neuroendocrine system, and are located in organs such as the stomach, intestines, pancreas, and lungs. Neuroendocrine tumors are malignant and benign tumors that affect an estimated 47,300 individuals in Europe and the United States each year. The commercial product, a single dose kit for the preparation of a 68Ga-Dotatate injection manufactured by Advanced Accelerator Applications of Saint Genis-Pouilly, France, has been given the market name NETSPOT ™. Food and Drug Administration (FDA) approved the use of gallium 68Ga-Dotatate, a radioactive diagnostic agent for positron emission tomography (PET) imaging to locate somostatin receptor positive neuroendocrine tumors in adult and pediatric patients. If you notice other side effects that you think are caused by this medicine, tell your doctor Call your doctor for medical advice about side effects.The U.S.
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