Issued to Swedish Orphan Biovitrum AB (publ). Application reviewed but not approved; deficiencies must be corrected.
Issued
June 26, 2026Application
BLA • 761438
Product
BLA 761438
Company
Swedish Orphan Biovitrum AB (publ)
Stage
Final Decision
Assyro regulatory brief
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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.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Swedish Orphan Biovitrum AB (publ) on June 26, 2026.
BLA 761438 is the application under which FDA issued this complete response letter to Swedish Orphan Biovitrum AB (publ). The letter is dated June 26, 2026.
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.