Issued to Accord Healthcare Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 10, 2024Application
NDA 505b1 • 216987
Product
Unknown
Company
Accord Healthcare Inc.
Review center
CDERStage
Final Decision
Response due
May 10, 2025
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 Accord Healthcare Inc. on May 10, 2024.
NDA 216987 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 May 10, 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.