federal_register: 2012-3234

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2012-3234 Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Bioequivalence Recommendations for Rifaximin,'' one for the 200- milligram (mg) strength (rifaximin-200) and one for the 550-mg strength (rifaximin-550). The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for rifaximin tablets. 2012-02-13 2012 2 https://www.federalregister.gov/documents/2012/02/13/2012-3234/draft-guidance-for-industry-on-bioequivalence-recommendations-for-rifaximin-tablets-availability https://www.govinfo.gov/content/pkg/FR-2012-02-13/pdf/2012-3234.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of two draft guidances for industry entitled ``Bioequivalence Recommendations for Rifaximin,'' one for the 200- milligram (mg) strength (rifaximin-200) and one for the 550-mg...

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