Issued to Minerva Neurosciences, Inc. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 26, 2024Application
NDA 505b1 • 217002
Product
roluperidone
Company
Minerva Neurosciences, Inc
Review center
CDERStage
Final Decision
Response due
February 25, 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 Minerva Neurosciences, Inc on February 26, 2024.
NDA 217002 is the application under which FDA issued this complete response letter for roluperidone to Minerva Neurosciences, Inc. It was reviewed by FDA CDER. The letter is dated February 26, 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.