FDAsafety guidance66% confidence
FDA AP — UTEBZI (ORIG)
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 NDA215960. Sponsor: GLAXOSMITHKLINE LLC. Submission status: AP. Submission type: ORIG. Review priority: PRIORITY. Active ingredients: TEBIPENEM, PIVOXIL.
Supporting Context
- Therapeutic area
- Infectious Disease · Antibiotic
- Sub-indication
- General
Related signal: FDA Grants Priority Review for UTEBZI (TEBIPENEM, PIVOXIL) by GlaxoSmithKline