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Manufacturing issues trip up Milestone's long-awaited FDA landmark
The FDA has rejected Milestone Pharmaceuticals’ application for approval of Cardamyst (etripamil), a nasal spray to quell symptomatic episodes from paroxysmal supraventricular tachycardia (PSVT), which is a type of abnormal heart rhythm. The regulator cited a two key manufacturing, chemistry and control issues that need to be addressed.
The FDA has rejected Milestone Pharmaceuticals’ application for approval of Cardamyst (etripamil), a nasal spray to quell symptomatic episodes from paroxysmal supraventricular tachycardia (PSVT), which is a type of abnormal heart rhythm. The regulator cited a two key manufacturing, chemistry and control issues that need to be addressed.
