FDAsafety guidance66% confidence
FDA AP — ROCURONIUM BROMIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (nmus rehab) as Rocuronium Bromide; 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
- Anesthesia · Neuromuscular Blocker
- Sub-indication
- Nmus Rehab
Related signal: FDA Accepts Supplement Application for Rocuronium Bromide by Fresenius Kabi