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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA has approved Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) for treatment of fatty liver disease (Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with liver Fibrosis). The treatment is approved for adults with a once-daily, oral dosage of 80 – 100 mg based on actual body weight of patient. REZDIFFRA tablets are supplied in 60 mg, 80 mg, and 100 mg strengths for oral administration.
Rezdiffra however comes with certain warnings and precautions for drug induced liver toxicity and gall bladder related side effects. Using Rezdiffra along with statins (for cholesterol) may result significant drug interactions.
Resmetirom is a New Molecular Entity (CAS Number 920509-32-6). Rezdiffra received Breakthrough Therapy, Fast Track and Priority Review designations from FDA for treatment of fatty liver disease. Madrigal completed the rolling submission of its NDA in July 2023 and the NDA received the FDA approval in March 2024. As Resmetirom was granted Breakthrough Therapy designation in April 2023 for the treatment of patients with NASH, Madrigal was allowed to submit individual sections of its NDA as they were completed rather than waiting until the entire application was complete.
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