Issued to AFT Pharmaceuticals, Ltd.. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 22, 2017Application
NDA 505b1 • 209471
Product
COMBOGESIC
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 Chemistry, manufacturing, and controls, Clinical efficacy and substantial evidence, Safety and adverse events, Facility inspection and CGMP compliance. 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 December 22, 2017.
NDA 209471 is the application under which FDA issued this complete response letter for COMBOGESIC to AFT Pharmaceuticals, Ltd.. It was reviewed by FDA Other. The letter is dated December 22, 2017.
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.