Issued to Rocket Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 14, 2024Application
Other • 125806
Product
marnetegragene autotemcel
Company
Rocket Pharmaceuticals, Inc.
Review center
CBERStage
Final Decision
Response due
June 14, 2025
Assyro regulatory brief
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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 Rocket Pharmaceuticals, Inc. on June 14, 2024.
125806 is the application under which FDA issued this complete response letter for marnetegragene autotemcel to Rocket Pharmaceuticals, Inc.. It was reviewed by FDA CBER. The letter is dated June 14, 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.