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Cardamyst FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 31, 2023.

FDA Approved: No
Brand name: Cardamyst
Generic name: etripamil
Dosage form: Nasal Spray
Company: Milestone Pharmaceuticals Inc.
Treatment for: Paroxysmal Supraventricular Tachycardia

Cardamyst (etripamil) is a novel calcium channel blocker nasal spray in development for the treatment of paroxysmal supraventricular tachycardia and atrial fibrillation with a rapid ventricular rate (AFib-RVR).

Development timeline for Cardamyst

DateArticle
Mar 28, 2024Milestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia
Dec 26, 2023Milestone Pharmaceuticals Receives Refusal to File Letter from U.S. FDA for New Drug Application for Etripamil in the Treatment of PSVT
Oct 24, 2023Milestone Pharmaceuticals Announces Submission of New Drug Application to the U.S. FDA for Etripamil
Jun 20, 2023Milestone Pharmaceuticals Announces Publication of Results from Phase 3 RAPID Clinical Trial of Etripamil Nasal Spray in Patients with PSVT in The Lancet
Oct 17, 2022Milestone Pharmaceuticals Announces Positive Results from Phase 3 RAPID Clinical Trial of Etripamil Nasal Spray in Patients with Paroxysmal Supraventricular Tachycardia

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.