Posted by Michael Wonder on 28 Dec 2023
Milestone Pharmaceuticals receives refusal to file letter from US FDA for new drug application for etripamil in the treatment of PSVT
26 December 2023 - Milestone Pharmaceuticals announced today that the Company received a refusal to file letter from the US FDA for the new drug application for self-administered etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia.
Upon preliminary review, the FDA determined that the new drug application, submitted in October 2023, was not sufficiently complete to permit substantive review.
