FDA accepts NDA review of Progenics’ iobenguane I 131 for pheochromocytoma and paraganglioma

The Food and Drug Administration (FDA) accepts for review the New Drug Application (NDA) for iobenguane I 131 (Azedra, Progenics Pharmaceuticals) in patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors. The FDA granted Priority Review and has set an action date of April 30, 2018, under the Prescription Drug User Fee Act.

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