Issued to Venatorx Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 22, 2024Application
NDA 505b1 • 217556
Product
cefepime for injection and taniborbactam for injection, co-packaged for intravenous use
Company
Venatorx Pharmaceuticals, Inc.
Review center
CDERStage
Final Decision
Response due
February 21, 2025
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to 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 Venatorx Pharmaceuticals, Inc. on February 22, 2024.
NDA 217556 is the application under which FDA issued this complete response letter for cefepime for injection and taniborbactam for injection, co-packaged for intravenous use to Venatorx Pharmaceuticals, Inc.. It was reviewed by FDA CDER. The letter is dated February 22, 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.