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These highlights do not include all the information needed to use REZDIFFRA® safely and effectively. See full prescribing information for REZDIFFRA®. REZDIFFRA® (resmetirom) tablets, for oral useInitial U.S. Approval: 2024
Medication labelWhy this: Advisory · dailymed-prescription
REZDIFFRA® is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of MASH and fibrosis [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitations of Use Avoid use of REZDIFFRA in patients with decompensated cirrhosis [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
- generic_name
- resmetirom
- product_names
- Resmetirom, resmetirom, RESMETIROM
- ndc
- 82576-060, 82576-080, 82576-100, 82576-060-30, 82576-080-30, 82576-080-90, 82576-100-30, 82576-100-90
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en