Issued to Bio-Thera Solutions Ltd.. Application reviewed but not approved; deficiencies must be corrected.
Issued
November 19, 2021Application
BLA • 761198
Product
AVZIVI
Company
Bio-Thera Solutions Ltd.
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls. 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 Bio-Thera Solutions Ltd. on November 19, 2021.
BLA 761198 is the application under which FDA issued this complete response letter for AVZIVI to Bio-Thera Solutions Ltd.. It was reviewed by FDA Other. The letter is dated November 19, 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.