Issued to BendaRx USA Corporation. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 17, 2024Application
NDA 505b1 • 215291
Product
Unknown
Company
BendaRx USA Corporation
Review center
CDERStage
Final Decision
Response due
January 16, 2025
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, Nonclinical 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 BendaRx USA Corporation on January 17, 2024.
NDA 215291 is the application under which FDA issued this complete response letter for Unknown to BendaRx USA Corporation. It was reviewed by FDA CDER. The letter is dated January 17, 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.