FDAsafety guidance72% confidence
FDA AP — WELIREG (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Merck.
Regulatory Analysis
Application NDA215383. Sponsor: MERCK SHARP DOHME. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: BELZUTIFAN.
Supporting Context
- Therapeutic area
- Diabetes · Pharmacokinetics
- Sub-indication
- General
Related signal: Merck's MK-1403 Trial Targets Type 2 Diabetes and hsCRP Levels