Issued to Sun Pharmaceutical Industries Limited. Application reviewed but not approved; deficiencies must be corrected.
Issued
November 24, 2015Application
NDA 505b1 • 208313
Product
INFUGEM
Company
Sun Pharmaceutical Industries Limited
Review center
Other
Stage
Final Decision
Response due
January 1, 2019
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, Clinical efficacy and substantial evidence, 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 Sun Pharmaceutical Industries Limited on November 24, 2015.
NDA 208313 is the application under which FDA issued this complete response letter for INFUGEM to Sun Pharmaceutical Industries Limited. It was reviewed by FDA Other. The letter is dated November 24, 2015.
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.