FDAsafety guidance72% confidence
FDA notification regarding unapproved drugs included in kits
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Sandoz.
Regulatory Analysis
On September 20, 2024, FDA requested Azurity Pharmaceuticals Inc. stop distributing unapproved drugs marketed as “Unit-of-Use Prescription Compounding Kits.
Supporting Context
- Therapeutic area
- Cardiovascular · Anticoagulant
- Sub-indication
- General
Related signal: Sandoz Issues Class 4 Medicines Defect Notification for Apixaban Tablets