Issued to Ascendis Pharma Bone Diseases A/S. Application reviewed but not approved; deficiencies must be corrected.
Issued
April 28, 2023Application
NDA 505b1 • 216490
Product
YORVIPATH
Company
Ascendis Pharma Bone Diseases A/S
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Clinical efficacy and substantial evidence, Safety and adverse events. 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 Ascendis Pharma Bone Diseases A/S on April 28, 2023.
NDA 216490 is the application under which FDA issued this complete response letter for YORVIPATH to Ascendis Pharma Bone Diseases A/S. It was reviewed by FDA Other. The letter is dated April 28, 2023.
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.