Milestone Pharmaceuticals Announces FDA Acceptance of New Drug Application for CARDAMYST™
The FDA Prescription Drug User Fee Act (PDUFA) target date is 10 months from the acceptance date of May 26, 2024.
- The FDA Prescription Drug User Fee Act (PDUFA) target date is 10 months from the acceptance date of May 26, 2024.
- “The FDA’s acceptance of our NDA for CARDAMYST brings Milestone one step closer in our mission in providing a new, convenient and effective treatment option for patients with PSVT,” said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals.
- “We understand the frequent impact that PSVT has on patients, as well as the underappreciated burden it places on their families and caregivers.
- Milestone continues to advance commercial preparations to support the anticipated launch of etripamil with the proposed trade name, CARDAMYST.