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
XYOSTED (AUTOINJECTOR) — FDA Complete Response Letter (NDA 209863)
Issued to Antares Pharma, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 20, 2017Application
NDA 505b1 • 209863
Product
XYOSTED (AUTOINJECTOR)
Company
Antares Pharma, Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2020
Assyro regulatory brief
FreeWhat did FDA decide for XYOSTED (AUTOINJECTOR)?
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Key details in this letter
- 1Labeling, packaging, and proprietary name: 13 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 XYOSTED (AUTOINJECTOR) complete response letter
What does this complete response letter mean for XYOSTED (AUTOINJECTOR)?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Antares Pharma, Inc. on October 20, 2017.
What is NDA 209863?
NDA 209863 is the application under which FDA issued this complete response letter for XYOSTED (AUTOINJECTOR) to Antares Pharma, Inc.. It was reviewed by FDA Other. The letter is dated October 20, 2017.
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.