FDAsafety guidance66% confidence
FDA AP — BREXAFEMME (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for GSK; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA214900. Sponsor: GLAXOSMITHKLINE. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: IBREXAFUNGERP CITRATE.
Supporting Context
- Therapeutic area
- Infectious Disease · Antifungal
- Sub-indication
- General
Related signal: FDA Approves Supplemental Application for Brexafemme (Ibrexafungerp) by GlaxoSmithKline