Issued to Apiject Systems Corp.. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 21, 2026Application
NDA 505b1 • 219107
Product
NDA 219107
Company
Apiject Systems Corp.
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, Device constituent and human factors, Safety and adverse events. 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 Apiject Systems Corp. on July 21, 2026.
NDA 219107 is the application under which FDA issued this complete response letter to Apiject Systems Corp.. The letter is dated July 21, 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.