FDAsafety guidance77% confidence
FDA AP — ARGATROBAN IN 0.9% SODIUM CHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (nmus rehab) as Teva; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA206769. Sponsor: TEVA PHARMS USA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ARGATROBAN.
Supporting Context
- Therapeutic area
- Anesthesia · Neuromuscular Blockade
- Sub-indication
- Nmus Rehab
Related signal: Teva's Sugammadex Sodium Receives FDA Approval Status