Issued to Accord Healthcare Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
November 6, 2025Application
NDA 505b1 • 216987
Product
NDA 216987
Company
Accord Healthcare Inc.
Stage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance, Labeling, packaging, and proprietary name. 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 November 6, 2025.
NDA 216987 is the application under which FDA issued this complete response letter to Accord Healthcare Inc.. The letter is dated November 6, 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.