Cardamyst (etripamil)

New molecular entity

Region: 🇺🇸 US
Active substance: etripamil
Company: Milestone Pharms Usa
Status: Approved
FDA approval: Fri 12 Dec 2025
Designations: New molecular entity
Application: NDA218571
Official record: www.accessdata.fda.gov

Regulatory milestones

Sat 13 Dec 2025🇺🇸 PDUFA datecompany-announced

CARDAMYST: PDUFA target action date (paroxysmal supraventricular tachycardia (PSVT))

Milestone Pharmaceuticals Inc. (MIST); etripamil; NDA; status: set; "Exhibit 99.1 Milestone Pharmaceuticals Reports Third Quarter 2025 Financial Results and Provides Regulatory and Corporate Update PDUFA Target Date of December 13, 2025 for CARDAMYST™ (etripamil) Nasal Spray in Paroxysmal Supraventricular Tachycardia (PSVT) Promotional Launch Plans Set w"; filed 2025-11-12 · source

Fri 12 Dec 2025🇺🇸 FDA approval

FDA approves Cardamyst (etripamil), a new medicine

Milestone Pharms Usa; NDA218571; New molecular entity; spray · source

Follow Cardamyst

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

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.