FDA Accepts Filing of Abbreviated NDA for Generic Lutathera

FDA Accepts Filing of Abbreviated NDA for Generic Lutathera in GEP-NETs

The FDA has accepted the filing of an abbreviated new drug application (ANDA) for Lutetium Lu 177 Dotatate, a generic version of lutetium Lu 177 dotatate indicated for the treatment of patients with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors in adults.

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