Issued to Bayer HealthCare LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 13, 2024Application
NDA 505b1 • 218506
Product
Unknown
Company
Bayer HealthCare LLC
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance, Labeling, packaging, and proprietary name, Nonclinical evidence. 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 Bayer HealthCare LLC on June 13, 2024.
NDA 218506 is the application under which FDA issued this complete response letter for Unknown to Bayer HealthCare LLC. It was reviewed by FDA CDER. The letter is dated June 13, 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.