Issued to Accord Healthcare Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
April 17, 2024Application
NDA 505b1 • 218762
Product
Unknown
Company
Accord Healthcare Inc.
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, 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 Accord Healthcare Inc. on April 17, 2024.
NDA 218762 is the application under which FDA issued this complete response letter for Unknown to Accord Healthcare Inc.. It was reviewed by FDA CDER. The letter is dated April 17, 2024.
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.