AAA receives orphan drug designation from FDA and EMA for Gallium-68 DOTATATE for use in patients with Gastro-Entero-Pancreatic Neuroendocrine Tumors
Martedì 04 Marzo 2014 14:22
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Advanced Accelerator Applications (“AAA”) announced that 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 U.S. and Europe.
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