FDA Grants Orphan Drug Designation to Gallium-68 DOTATOC for Neuroendocrine Tumor Management

BREAKING NEWS – The radiopharmaceutical Gallium-68 (DOTA0-hel-Tyr3) octreotide (Ga-68 DOTATOC) has been designated as an orphan drug by the US Food and Drug Administration (FDA) for the management of neuroendocrine tumors. This designation is significant because it may lead to faster approval of the agent, which would greatly benefit carcinoid/NET patients in the United States. Read more from the Society of Nuclear Medicine and Molecular Imaging and from Josh Mailman, chairman of the Society’s Patient Advocacy Advisory Board and president of the NorCal CarciNET support group in California. From the FDA, here’s information about how drugs are designated as an orphan product, read more.

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