Issued to Elevar Therapeutics, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 20, 2025Application
NDA 505b1 • 216586
Product
rivoceranib tablets
Company
Elevar Therapeutics, Inc.
Review center
CDERStage
Final Decision
Response due
March 20, 2026
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events. 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 Elevar Therapeutics, Inc. on March 20, 2025.
NDA 216586 is the application under which FDA issued this complete response letter for rivoceranib tablets to Elevar Therapeutics, Inc.. It was reviewed by FDA CDER. The letter is dated March 20, 2025.
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.