Issued to Accord BioPharma Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 29, 2024Application
BLA • 761147
Product
ENNUMO
Company
Accord BioPharma Inc.
Review center
CBERStage
Final Decision
Response due
October 29, 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 BioPharma Inc. on October 29, 2024.
BLA 761147 is the application under which FDA issued this complete response letter for ENNUMO to Accord BioPharma Inc.. It was reviewed by FDA CBER. The letter is dated October 29, 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.