Issued to Provention Bio, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 2, 2021Application
BLA • 761183
Product
TZIELD
Company
Provention Bio, Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2024
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, 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 Provention Bio, Inc. on July 2, 2021.
BLA 761183 is the application under which FDA issued this complete response letter for TZIELD to Provention Bio, Inc.. It was reviewed by FDA Other. The letter is dated July 2, 2021.
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.