FDAsafety guidance72% confidence
FDA AP — TICAGRELOR (ORIG)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Janssen Scientific Affairs, LLC.
Regulatory Analysis
Application ANDA208539. Sponsor: MICRO LABS. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: TICAGRELOR.
Supporting Context
- Therapeutic area
- Neurology · Stroke
- Sub-indication
- General
Related signal: Trial Compares Rivaroxaban and Ticagrelor Against Clopidogrel for Stroke Prevention