Source facts
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
US FDA source recordCRL · Complete Response Letter
Unknown — FDA Complete Response Letter (NDA 218026)
Issued to Antares Pharma, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
August 16, 2024Application
NDA 505b1 • 218026
Product
Unknown
Company
Antares Pharma, Inc.
Review center
CDERStage
Final Decision
Response due
August 16, 2025
Assyro regulatory brief
FreeWhat did FDA decide for Unknown?
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Key details in this letter
- 1Labeling, packaging, and proprietary name: 24 source-text matches.
Labeling, packaging, and proprietary name
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the Unknown complete response letter
What does this complete response letter mean for Unknown?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Antares Pharma, Inc. on August 16, 2024.
What is NDA 218026?
NDA 218026 is the application under which FDA issued this complete response letter for Unknown to Antares Pharma, Inc.. It was reviewed by FDA CDER. The letter is dated August 16, 2024.
What happens after an FDA complete response letter?
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.