Milestone Pharmaceuticals sumbits CRL response for CARDAMYST nasal spray

Milestone announced submission of its response to the U.S. Food and Drug Administration’s Complete Response Letter regarding its New Drug Application for CARDAMYST 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 Prescription Drug User Fee Act date will be determined within the next thirty days per FDA policy. The review time is expected to be within 2 or 6 months from the resubmission, depending on the classification.