NDA 218571, held by Milestone Pharms USA. Etripamil.
As of Nov 13, 2026, NDA 218571 (Cardamyst), held by Milestone Pharms USA, was first approved by FDA on Dec 12, 2025, with 0 approved supplements and 1 published complete response letter.
CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 12, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Mar 27, 2025 | EtripamilProduct Quality, Facility Inspections | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cardamyst70MG · spray;nasal | Etripamil | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
