FDAsafety guidance83% confidence
FDA AP — ENLICITIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Merck Sharp & Dohme LLC.
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
- Gastroenterology · Acute Pancreatitis
- Sub-indication
- General
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