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# Cortisporin Not Withdrawn Due to Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/cortisporin-not-withdrawn-due-to-safety-efficacy-fda/
- Published: 2019-04-05T12:00:00.000Z
- Updated: 2026-09-15T01:18:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143800

*Federal Register* notice: FDA determines that Monarch Pharmaceuticals’ Cortisporin (hydrocortisone/neomycin sulfate/polymyxin B sulfate) was not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to approve ANDAs that reference the drug product as long as they meet relevant legal and regulatory requirements. Cortisporin is indicated for treating superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-04-04/pdf/2019-06549.pdf?ref=fdaweb.com).