Monday, June 1, 2026
Approved
approved Note: Approved 2026-06-17 as UTEBZI (ORIG NDA215960). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 16d from the PDUFA date.
Drug Information
- Drug Name
- tebipenem HBr (CT.gov)
- Indication
- complicated urinary tract infections (cUTIs), including pyelonephritis
- Approved As
- tebipenem HBr
Filing Details
- Company
- GSK plc →
- Stock Ticker
- GSK
- SEC CIK
- 0001131399
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue