FDAapproval84% 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 Merck; the same agency is already in play for this signal, so precedent weight is higher.
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
- Infectious Disease · HIV
- Sub-indication
- General
Related signal: FDA Approves Merck’s IDVYNSO for Virologically Suppressed HIV-1 Patients