FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Lutetium Lu 177 Dotatate (LUTATHERA) Injection
Status: Currently in Shortage
»Date first posted: 05/12/2022
»Therapeutic Categories: Oncology

Advanced Accelerator Applications USA, Inc. (Revised 05/16/2022)

Company Contact Information:
862-778-8300

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Lutathera® (lutetium Lu 177 dotatate) injection, for intravenous use 10 mCi/mL; Colorless Type I glass 30 mL single-dose vial containing 7.4 GBq (200 mCi) ± 10% of lutetium Lu 177 dotatate (NDC 69488-003-01) Currently unavailable; Return to market availability in approximately six weeks There are no therapeutic equivalents available Requirements related to complying with Good Manufacturing Practices

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