Issued to Chemo Research, S.L.. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 29, 2025Application
NDA 505b1 • 219029
Product
Unknown
Company
Chemo Research, S.L.
Review center
CDERStage
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, Safety and adverse events, Device constituent and human factors. 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 Chemo Research, S.L. on May 29, 2025.
NDA 219029 is the application under which FDA issued this complete response letter for Unknown to Chemo Research, S.L.. It was reviewed by FDA CDER. The letter is dated May 29, 2025.
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.