FDAsafety guidance66% confidence
FDA AP — ENLICITIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Merck; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA220848. Sponsor: MERCK SHARP AND DOHME LLC. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: ENLICITIDE CHLORIDE.
Supporting Context
- Therapeutic area
- Diabetes · SGLT2 Inhibitor
- Sub-indication
- General
Related signal: FDA Accepts Supplement for STEGLATRO (Ertugliflozin) by Merck