Issued to Ingenus Pharmaceuticals, LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 14, 2020Application
NDA 505b1 • 212501
Product
CYCLOPHOSPHAMIDE
Company
Ingenus Pharmaceuticals, LLC
Review center
Other
Stage
Final Decision
Response due
January 1, 2022
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, 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 Ingenus Pharmaceuticals, LLC on January 14, 2020.
NDA 212501 is the application under which FDA issued this complete response letter for CYCLOPHOSPHAMIDE to Ingenus Pharmaceuticals, LLC. It was reviewed by FDA Other. The letter is dated January 14, 2020.
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.