FDAsafety guidance66% confidence
FDA AP — CAMCEVI ETM (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Accord Biopharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA219745. Sponsor: ACCORD. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LEUPROLIDE MESYLATE.
Supporting Context
- Therapeutic area
- Hematology · Neutropenia
- Sub-indication
- General
Related signal: FDA Accepts BLA761147 for PEGFILGRASTIM-PCCG by Accord Biopharma