Issued to AFT Pharmaceuticals Ltd.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 30, 2022Application
NDA 505b1 • 215320
Product
COMBOGESIC IV
Company
AFT Pharmaceuticals Ltd.
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
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. 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 AFT Pharmaceuticals Ltd. on June 30, 2022.
NDA 215320 is the application under which FDA issued this complete response letter for COMBOGESIC IV to AFT Pharmaceuticals Ltd.. It was reviewed by FDA Other. The letter is dated June 30, 2022.
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.