Source facts
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
US FDA source recordCRL · Complete Response Letter
RAPIBLYK — FDA Complete Response Letter (NDA 217202)
Issued to AOP Orphan Pharmaceuticals GmbH. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 31, 2023Application
NDA 505b1 • 217202
Product
RAPIBLYK
Company
AOP Orphan Pharmaceuticals GmbH
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
Assyro regulatory brief
FreeWhat did FDA decide for RAPIBLYK?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1Labeling, packaging, and proprietary name: 26 source-text matches.
Labeling, packaging, and proprietary name
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
Open the document workspaceFDA source document
Read the full FDA complete response letter (PDF)
Loading document viewer…
Common questions about the RAPIBLYK complete response letter
What does this complete response letter mean for RAPIBLYK?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to AOP Orphan Pharmaceuticals GmbH on May 31, 2023.
What is NDA 217202?
NDA 217202 is the application under which FDA issued this complete response letter for RAPIBLYK to AOP Orphan Pharmaceuticals GmbH. It was reviewed by FDA Other. The letter is dated May 31, 2023.
What happens after an FDA complete response letter?
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.