FDAsafety guidance83% confidence
FDA AP — ARGATROBAN IN 0.9% SODIUM CHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Teva.
Regulatory Analysis
Application NDA206769. Sponsor: TEVA PHARMS USA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ARGATROBAN.
Supporting Context
- Therapeutic area
- Not specified · Not specified
- Sub-indication
- General
Related signal: Teva initiates trial for TEV-56286 assessing pharmacokinetics and safety