Issued to Applied Therapeutics, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
November 27, 2024Application
NDA 505b1 • 219195
Product
govorestat
Company
Applied Therapeutics, Inc.
Review center
CDERStage
Final Decision
Response due
November 27, 2025
Assyro regulatory brief
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Applied Therapeutics, Inc. on November 27, 2024.
NDA 219195 is the application under which FDA issued this complete response letter for govorestat to Applied Therapeutics, Inc.. It was reviewed by FDA CDER. The letter is dated November 27, 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.