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# Takeda’s Omontys Withdrawm Due to Adverse Events
- URL: https://www.fdaweb.com/takedas-omontys-withdrawm-due-to-adverse-events/
- Published: 2019-02-14T12:00:00.000Z
- Updated: 2026-09-15T01:04:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143384

*Federal Register* notice: FDA has announced the withdrawal of a Takeda Pharmaceuticals NDA for Omontys (peginesatide) injection, indicated for treating anemia due to chronic kidney disease in adult patients on dialysis. The drug was approved in 2012, but in 2013 all lots were voluntarily recalled and marketing was suspended due to post-marketing reports about serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. Takeda subsequently requested that FDA withdraw its approval. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-02-13/pdf/2019-02146.pdf?ref=fdaweb.com).