Posted by Michael Wonder on 17 Jun 2025
Milestone Pharmaceuticals submits response to the FDA’s CRL for Cardamyst (etripamil) nasal spray for PSVT following type A meeting
16 June 2025 - Milestone Pharmaceuticals today announced submission of its response to the US FDA’s complete response letter regarding its new drug application for Cardamyst (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of paroxysmal supraventricular tachycardia to sinus rhythm in adults.
The response follows a type A meeting recently held with the FDA. The acceptance of the response and corresponding PDUFA date will be determined within the next thirty days per FDA policy.
