FDAsafety guidance83% confidence
FDA AP — OPZELURA (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as Incyte.
Regulatory Analysis
Application NDA215309. Sponsor: INCYTE CORP. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: RUXOLITINIB PHOSPHATE.
Supporting Context
- Therapeutic area
- Dermatology · Nonsegmental Vitiligo
- Sub-indication
- Ild
Related signal: Incyte's Ruxolitinib Cream Shows Promise for Pediatric Nonsegmental Vitiligo