FDAapproval95% 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: sets a approval precedent in the same sub-indication (pain) as Amphastar Pharmaceuticals; 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
- Neurology · Opioid Overdose
- Sub-indication
- Pain
Related signal: FDA Approves Supplemental Application for REXTOVY by Amphastar Pharmaceuticals