Issued to CELLTRION, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 28, 2018Application
BLA • 761088
Product
TRUXIMA
Company
CELLTRION, Inc.
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, Chemistry, manufacturing, and controls, Safety and adverse events, 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 CELLTRION, Inc. on February 28, 2018.
BLA 761088 is the application under which FDA issued this complete response letter for TRUXIMA to CELLTRION, Inc.. It was reviewed by FDA Other. The letter is dated February 28, 2018.
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.