FDA, EMA Grant Orphan Drug Status to Gallium-68 Dotatate Radiopharmaceutical
Advanced Accelerator Applications (AAA), a growing international player in molecular nuclear medicine, announced they have received orphan drug designation status for their radiopharmaceutical, Gallium-68 Dotatate. The orphan drug designation has been granted by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for use of Gallium-68 Dotatate as a diagnostic agent for the management of gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs). The designation should foster rapid development of the agent for the benefit of GEP-NET patients in the United States and Europe.
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