Issued to Tris Pharma, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 25, 2018Application
NDA 505b1 • 210526
Product
DYANAVEL XR 5 / DYANAVEL XR 10 / DYANAVEL XR 15
Company
Tris Pharma, Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2023
Assyro regulatory brief
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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, Facility inspection and CGMP compliance. 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 Tris Pharma, Inc. on July 25, 2018.
NDA 210526 is the application under which FDA issued this complete response letter for DYANAVEL XR 5 / DYANAVEL XR 10 / DYANAVEL XR 15 to Tris Pharma, Inc.. It was reviewed by FDA Other. The letter is dated July 25, 2018.
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.