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Search results for "ORPHAN DRUG|Designated/Approved|Diagnostic for the management of neuroendocrine tumors." in comments (approximate match)
Showing 1 - 1 of 1 results
Status:
US Approved Rx
(2020)
Source:
NDA213227
(2020)
Source URL:
First approved in 2016
Source:
NDA208547
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Dotatate, also known as DOTA-0-Tyr3-Octreotate, is a cyclic 8 amino acid peptide with a covalently bound chelator (dota). The peptide has the amino acid sequence: H-D-Phe-Cys-Tyr-D-Trp-Lys-ThrCys-Thr-OH, and contains one disulfide bond. After radiolabeling with Ga 68 (NETSPOT®) or with Lu 177 (LUTATHERA®), it is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
