FDAsafety guidance72% confidence
FDA AP — RINVOQ LQ (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (immunology) as AbbVie.
Regulatory Analysis
Application NDA218347. Sponsor: ABBVIE. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: UPADACITINIB.
Supporting Context
- Therapeutic area
- Dermatology · Atopic Dermatitis
- Sub-indication
- Immunology
Related signal: AbbVie Trials Upadacitinib for Moderate-to-Severe Atopic Dermatitis in Dupilumab Inadequate Responders