Issued to Takeda Pharmaceuticals, U.S.A., Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 17, 2019Application
BLA • 761133
Product
ENTYVIO
Company
Takeda Pharmaceuticals, U.S.A., Inc.
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors, 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.
Open the document workspaceFDA source document
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Takeda Pharmaceuticals, U.S.A., Inc. on December 17, 2019.
BLA 761133 is the application under which FDA issued this complete response letter for ENTYVIO to Takeda Pharmaceuticals, U.S.A., Inc.. It was reviewed by FDA Other. The letter is dated December 17, 2019.
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.