Issued to ResQ Pharma. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 2, 2025Application
NDA 505b1 • 217382
Product
Nutrilipid 20%
Company
ResQ Pharma
Review center
CDERStage
Final Decision
Response due
June 2, 2026
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
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, Device constituent and human factors. 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.
Open the document workspaceFDA source document
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to ResQ Pharma on June 2, 2025.
NDA 217382 is the application under which FDA issued this complete response letter for Nutrilipid 20% to ResQ Pharma. It was reviewed by FDA CDER. The letter is dated June 2, 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.