FDAsafety guidance83% confidence
FDA AP — ZURZUVAE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Biogen.
Regulatory Analysis
Application NDA217369. Sponsor: BIOGEN. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ZURANOLONE.
Supporting Context
- Therapeutic area
- Immunology · Lupus
- Sub-indication
- General
Related signal: Biogen's Litifilimab (BIIB059) Study Targets Active Cutaneous Lupus Erythematosus