Utebzi (tebipenem pivoxil hydrobromide)
New molecular entityPriority review
- Region
- 🇺🇸 US
- Active substance
- tebipenem pivoxil hydrobromide
- Company
- Glaxosmithkline
- Status
- Approved
- FDA approval
- Wed 17 Jun 2026
- Designations
- New molecular entity, Priority review
- Application
- NDA215960
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Thu 18 Jun 2026🇺🇸 PDUFA datecompany-announced
Utebzi: PDUFA target action date (complicated urinary tract infections (cUTI), including pyelonephritis, in adults with limited or no alternative oral tre)
Spero Therapeutics, Inc. (SPRO); tebipenem pivoxil; status: met; "FDA approval was received in advance of FDA-assigned Prescription Drug User Fee Act (“PDUFA”) date of June 18, 2026."; filed 2026-06-22 · source
Wed 17 Jun 2026🇺🇸 FDA approval
FDA approves Utebzi (tebipenem pivoxil hydrobromide), a new medicine
Glaxosmithkline; NDA215960; New molecular entity, Priority review; tablet · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.