FDAsafety guidance66% confidence
FDA AP — ROCURONIUM BROMIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for SPRINGWORKS; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA217472. Sponsor: FRESENIUS KABI USA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ROCURONIUM BROMIDE.
Supporting Context
- Therapeutic area
- Oncology · Small Molecule
- Sub-indication
- General
Related signal: FDA Approves Supplemental Application for OGSIVEO (Nirogacestat Hydro bromide)