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# FDA Withdraws 5 Bacitracin ANDAs
- URL: https://www.fdaweb.com/fda-withdraws-5-bacitracin-andas/
- Published: 2021-03-12T12:00:00.000Z
- Updated: 2026-09-14T16:50:39.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148869

*Federal Register* notice: FDA is withdrawing approval of five bacitracin for injection ANDAs from multiple holders — Akorn, Mylan, Pfizer, X–Gen Pharmaceuticals and Fresenius Kabi. The ANDA holders requested the action in response to a 1/2020 agency withdrawal request due to serious risks, including nephrotoxicity and anaphylactic reactions. In 4/2019, FDA’s Antimicrobial Drugs Advisory Committee voted almost unanimously, with one abstention, that the benefits of bacitracin for intramuscular injection do not outweigh the risks. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-03-12/pdf/2021-05105.pdf?ref=fdaweb.com).