Issued to Samsung Bioepis Co., Ltd.. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 23, 2018Application
BLA • 761066
Product
ETICOVO
Company
Samsung Bioepis Co., Ltd.
Review center
Other
Stage
Final Decision
Response due
January 1, 2020
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. 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 Samsung Bioepis Co., Ltd. on March 23, 2018.
BLA 761066 is the application under which FDA issued this complete response letter for ETICOVO to Samsung Bioepis Co., Ltd.. It was reviewed by FDA Other. The letter is dated March 23, 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.