FDAsafety guidance83% confidence
Hepatitis C Medicines (Mavyret, Zepatier, and Vosevi): Drug Safety Communication - Due to Rare Occurrence of Serious Liver Injury in Some patients with Advanced Liver Disease
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Sandoz.
Regulatory Analysis
FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.
Supporting Context
- Therapeutic area
- Cardiovascular · Anticoagulant
- Sub-indication
- General
Related signal: Sandoz Issues Class 4 Medicines Defect Notification for Apixaban Tablets