FDAapproval72% confidence
FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable approval decision relevant to Biogen.
Regulatory Analysis
The FDA has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication.
Supporting Context
- Therapeutic area
- Nephrology · Kidney Transplant
- Sub-indication
- General
Related signal: Biogen's Felzartamab Study Targets Isolated Microvascular Inflammation in Kidney Transplant Patients