GSK

GSK plc

FDA PDUFA Target Action Date

Monday, June 1, 2026

6 days away

Drug Information

Drug Name: tebipenem HBr (CT.gov)
Indication: complicated urinary tract infections (cUTIs), including pyelonephritis

Filing Details

Company: GSK plc →
Stock Ticker: GSK
SEC CIK: 0001131399
Source: SEC EDGAR (LLM-extracted from primary filing) →

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

Explore GSK plc

View GSK plc's full pipeline, approved drugs, and clinical trials.

View Pipeline → FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue