Issued to Xspray Pharma AB. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 4, 2026Application
NDA 505b1 • 217644
Product
NDA 217644
Company
Xspray Pharma AB
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, Clinical efficacy and substantial evidence, Bioequivalence and pharmacokinetics. 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 Xspray Pharma AB on June 4, 2026.
NDA 217644 is the application under which FDA issued this complete response letter to Xspray Pharma AB. The letter is dated June 4, 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.