FDAsafety guidance66% confidence
FDA TA — ANDA219207
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (immunology) as Roche; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA219207. Sponsor: SHANGHAI AUCYUN PHARMACEUTICALS CO., LTD. Submission status: TA. Submission type: ORIG. Review priority: STANDARD.
Supporting Context
- Therapeutic area
- Nephrology · Autoimmune Disease
- Sub-indication
- Immunology
Related signal: FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for primary membranous nephropathy