Issued to MediWound, Ltd.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 25, 2021Application
BLA • 761192
Product
NEXOBRID
Company
MediWound, Ltd.
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 Chemistry, manufacturing, and controls, Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, 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 MediWound, Ltd. on June 25, 2021.
BLA 761192 is the application under which FDA issued this complete response letter for NEXOBRID to MediWound, Ltd.. It was reviewed by FDA Other. The letter is dated June 25, 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.