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# Guidance on Fidaxomicin Bioequivalence Studies
- URL: https://www.fdaweb.com/guidance-on-fidaxomicin-bioequivalence-studies/
- Published: 2016-08-24T12:00:00.000Z
- Updated: 2026-09-14T21:26:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136600

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled Draft Guidance on Fidaxomicin. The recommendations provide specific guidance on the design of bioequivalence studies to support ANDAs for fidaxomicin tablets. To download this guidance, click [here](http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm517624.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-08-24/pdf/2016-20146.pdf?ref=fdaweb.com).