FDAsafety guidance72% confidence
FDA AP — ZEGALOGUE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Roche.
Regulatory Analysis
Application NDA214231. Sponsor: ZEALAND PHARMA. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: DASIGLUCAGON HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Endocrinology · Obesity
- Sub-indication
- General
Related signal: Hoffmann-La Roche Evaluates Petrelintide and Enicepatide in Obesity Trial