Issued to Hospira, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 17, 2025Application
NDA 505b1 • 219112
Product
Unknown
Company
Hospira, Inc.
Review center
CDERStage
Final Decision
Response due
January 17, 2026
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Hospira, Inc. on January 17, 2025.
NDA 219112 is the application under which FDA issued this complete response letter for Unknown to Hospira, Inc.. It was reviewed by FDA CDER. The letter is dated January 17, 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.