federal_register: 2016-28334

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2016-28334 Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic cyclobenzaprine hydrochloride extended release capsules, entitled "Draft Guidance on Cyclobenzaprine Hydrochloride." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclobenzaprine hydrochloride extended release capsules. 2016-11-25 2016 11 https://www.federalregister.gov/documents/2016/11/25/2016-28334/bioequivalence-recommendations-for-cyclobenzaprine-hydrochloride-revised-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2016-11-25/pdf/2016-28334.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic cyclobenzaprine hydrochloride extended release capsules, entitled "Draft Guidance on Cyclobenzaprine...

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