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Milestone Pharmaceuticals Resubmits Etripamil New Drug Application to FDA
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Milestone Pharmaceuticals Resubmits Etripamil New Drug Application to FDA
Mar 28, 2024 8:23 AM

10:56 AM EDT, 03/28/2024 (MT Newswires) -- Milestone Pharmaceuticals ( MIST ) said Thursday that it has resubmitted its new drug application to the US Food and Drug Administration for etripamil, an investigational nasal spray for the management of paroxysmal supraventricular tachycardia, or PSVT.

PSVT is a type of arrhythmia or abnormal heart rhythm characterized by episodes of sudden onset rapid heartbeats, the company said.

The resubmission was based on guidance from a Type A meeting with the regulator, which followed receipt of a Refusal to File letter, the company said.

The resubmission package included certain restructured data sets and reformatted data files. The letter didn't request any additional efficacy or safety data, the company added.

Shares of Milestone Pharmaceuticals ( MIST ) rose 4.4% in recent trading.

Price: 1.88, Change: +0.08, Percent Change: +4.44

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