FDAsafety guidance66% confidence
FDA AP — METHYLERGONOVINE MALEATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Amneal Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA211483. Sponsor: AMNEAL PHARMS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: METHYLERGONOVINE MALEATE.
Supporting Context
- Therapeutic area
- Obstetrics · Uterotonics
- Sub-indication
- General
Related signal: FDA Approval Update for Methylergomovine Maleate by Amneal Pharmaceuticals