Issued to Milestone Pharmaceuticals USA, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 27, 2025Application
NDA 505b1 • 218571
Product
CARDAMYST
Company
Milestone Pharmaceuticals USA, Inc.
Review center
CDERStage
Final Decision
Response due
March 27, 2026
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Milestone Pharmaceuticals USA, Inc. on March 27, 2025.
NDA 218571 is the application under which FDA issued this complete response letter for CARDAMYST to Milestone Pharmaceuticals USA, Inc.. It was reviewed by FDA CDER. The letter is dated March 27, 2025.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.