FDAsafety guidance83% confidence
FDA AP — TOFACITINIB CITRATE (ORIG)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Pfizer.
Regulatory Analysis
Application ANDA209738. Sponsor: MICRO LABS. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: TOFACITINIB CITRATE.
Supporting Context
- Therapeutic area
- Gastroenterology · Ulcerative Colitis
- Sub-indication
- General
Related signal: Pfizer's Phase 3 Study of Tofacitinib in Pediatric Ulcerative Colitis Underway