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
XELPROS — FDA Complete Response Letter (NDA 206185)
Issued to Sun Pharma Advanced Research Company Limited. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 19, 2016Application
NDA 505b1 • 206185
Product
XELPROS
Company
Sun Pharma Advanced Research Company Limited
Review center
Other
Stage
Final Decision
Response due
January 1, 2019
Assyro regulatory brief
FreeWhat did FDA decide for XELPROS?
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Key details in this letter
- 1Labeling, packaging, and proprietary name: 7 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 XELPROS complete response letter
What does this complete response letter mean for XELPROS?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Sun Pharma Advanced Research Company Limited on December 19, 2016.
What is NDA 206185?
NDA 206185 is the application under which FDA issued this complete response letter for XELPROS to Sun Pharma Advanced Research Company Limited. It was reviewed by FDA Other. The letter is dated December 19, 2016.
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.