Issued to Scienture Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
August 19, 2024Application
NDA 505b1 • 218772
Product
ARBLI
Company
Scienture Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2026
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Bioequivalence and pharmacokinetics. 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 Scienture Inc. on August 19, 2024.
NDA 218772 is the application under which FDA issued this complete response letter for ARBLI to Scienture Inc.. It was reviewed by FDA Other. The letter is dated August 19, 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.