FDAsafety guidance66% confidence
FDA AP — SUGAMMADEX SODIUM (ORIG)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (nmus rehab) as Sun Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA214368. Sponsor: MSN. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: SUGAMMADEX SODIUM.
Supporting Context
- Therapeutic area
- Anesthesia · Neuromuscular Blockade
- Sub-indication
- Nmus Rehab
Related signal: FDA Grants Approval for Sugammadex Sodium ANDA214319 by Sun Pharma