IRWD

LINZESS (linaclotide)

FDA PDUFA Target Action Date · IRONWOOD PHARMACEUTICALS INC

Sunday, May 24, 2026

Approved

approved

Note: Approved 2026-05-21 as LINZESS (SUPPL NDA202811). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 3d from the PDUFA date.

Drug Information

Drug Name: LINZESS (linaclotide) (CT.gov)
Application Type: sNDA
Indication: functional constipation (FC)
Approved As: LINZESS (linaclotide)

Filing Details

Company: IRONWOOD PHARMACEUTICALS INC →
Stock Ticker: IRWD
SEC CIK: 0001446847
Source: SEC EDGAR (LLM-extracted from primary filing via full-text search) →

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