Issued to Grace Therapeutics U.S., Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
April 23, 2026Application
NDA 505b1 • 220304
Product
NDA 220304
Company
Grace Therapeutics U.S., Inc.
Stage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Nonclinical evidence. 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 Grace Therapeutics U.S., Inc. on April 23, 2026.
NDA 220304 is the application under which FDA issued this complete response letter to Grace Therapeutics U.S., Inc.. The letter is dated April 23, 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.