TheraRadar
MIST

Milestone Pharmaceuticals Inc.

FDA PDUFA Target Action Date

Saturday, December 13, 2025
106 days ago
pending

Drug Information

Drug Name
CARDAMYST (etripamil nasal spray)
Indication
Paroxysmal supraventricular tachycardia (PSVT)

Filing Details

Company
Milestone Pharmaceuticals Inc.
Stock Ticker
MIST
SEC CIK
0001408443

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

Track All FDA Decisions

View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.

View FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2026-03-22. Report an issue