Issued to Alvotech USA, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 20, 2022Application
BLA • 761299
Product
SIMLANDI
Company
Alvotech USA, 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, 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 Alvotech USA, Inc. on December 20, 2022.
BLA 761299 is the application under which FDA issued this complete response letter for SIMLANDI to Alvotech USA, Inc.. It was reviewed by FDA Other. The letter is dated December 20, 2022.
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.