FDAsafety guidance65% confidence
FDA AP — TOFACITINIB CITRATE (ORIG)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as Aurobindo Pharma.
Regulatory Analysis
Application ANDA215356. Sponsor: AUROBINDO PHARMA LTD. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: TOFACITINIB CITRATE.
Supporting Context
- Therapeutic area
- Pulmonology · Idiopathic Pulmonary Fibrosis
- Sub-indication
- Ild
Related signal: Aurobindo Pharma's Pirfenidone ANDA Submission Receives AP Status