FDA issues complete response letter for etripamil for PSVT

Milestone Pharmaceuticals

28 March 2025 - Complete response letter focused on CMC; no clinical issues relating to etripamil raised.

Milestone Pharmaceuticals today announced the US FDA issued a 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 PSVT to sinus rhythm in adults.

Read Milestone Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Dossier