Issued to Lupin Limited (Biotech Division). Application reviewed but not approved; deficiencies must be corrected.
Issued
November 14, 2024Application
BLA • 761212
Product
ARMLUPEG
Company
Lupin Limited (Biotech Division)
Review center
CBERStage
Final Decision
Response due
November 14, 2025
Assyro regulatory brief
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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 Lupin Limited (Biotech Division) on November 14, 2024.
BLA 761212 is the application under which FDA issued this complete response letter for ARMLUPEG to Lupin Limited (Biotech Division). It was reviewed by FDA CBER. The letter is dated November 14, 2024.
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.