Issued to Rosemont Pharmaceuticals Holdings, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 5, 2026Application
NDA 505b1 • 220140
Product
NDA 220140
Company
Rosemont Pharmaceuticals Holdings, Inc.
Stage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance, Labeling, packaging, and proprietary name. 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 Rosemont Pharmaceuticals Holdings, Inc. on March 5, 2026.
NDA 220140 is the application under which FDA issued this complete response letter to Rosemont Pharmaceuticals Holdings, Inc.. The letter is dated March 5, 2026.
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.