GSK, GLAXF

GSK plc

FDA PDUFA Target Action Date

Thursday, December 11, 2025

166 days ago

approved

Drug Information

Approved As: EXDENSUR →

Filing Details

Company: GSK plc →
Stock Ticker: GSK, GLAXF
SEC CIK: 0001131399
Source: SEC 8-K 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: 2025-10-29. Report an issue