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# FDA Withdraws Xellia’s Bacitracin ANDA
- URL: https://www.fdaweb.com/fda-withdraws-xellias-bacitracin-anda/
- Published: 2022-07-11T12:00:00.000Z
- Updated: 2026-09-14T17:51:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152238

*Federal Register* notice: FDA is withdrawing the approval of Xellia Pharmaceuticals’ ANDA for bacitracin for injection, 50,000 units/vial, after the company requested it be withdrawn. The intramuscular antibiotic is used for treating infants with pneumonia and empyema caused by *staphylococci* shown to be susceptible to the drug. The agency determined in 2020 that bacitracin poses serious risks, including nephrotoxicity and anaphylactic reactions, and it requested the voluntary withdrawal. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-07-11/pdf/2022-14680.pdf?ref=fdaweb.com).