FDAsafety guidance66% confidence
FDA AP — DEMEROL (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Zealand Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA005010. Sponsor: QUAGEN. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: MEPERIDINE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Endocrinology · Diabetes
- Sub-indication
- General
Related signal: FDA Grants Priority Review for ZEGALOGUE Supplemental Application