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# FDA Withdraws Ciprofloxacin for Cystitis
- URL: https://www.fdaweb.com/fda-withdraws-ciprofloxacin-for-cystitis/
- Published: 2023-12-08T12:00:00.000Z
- Updated: 2026-09-14T14:18:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155957

*Federal Register* notice: FDA is withdrawing the approval of Bayer’s Cipro (ciprofloxacin HCl) oral tablets under NDA #019537 and five related ANDAs that referenced the NDA. The actions are based on the agency’s determination that the products’ effectiveness for treating acute uncomplicated cystitis is not supported by the current ciprofloxacin susceptibility test interpretive criteria (also known as breakpoints). The application holders have requested the products’ withdrawal and waived their opportunity for a hearing. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-12-08/pdf/2023-27015.pdf?ref=fdaweb.com).