FDAsafety guidance77% confidence
FDA AP — TOFACITINIB CITRATE (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Saptalis Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA209829. Sponsor: ZYDUS PHARMS. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: TOFACITINIB CITRATE.
Supporting Context
- Therapeutic area
- Immunology · JAK Inhibitor
- Sub-indication
- General
Related signal: FDA Grants Approval for Tofacitinib Citrate ANDA218900 by Saptalis Pharmaceuticals