Issued to United Therapeutics Corporation. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 2, 2017Application
NDA 505b1 • 208276
Product
REMODULIN
Company
United Therapeutics Corporation
Review center
Other
Stage
Final Decision
Response due
January 1, 2019
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Device constituent and human factors. 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 United Therapeutics Corporation on June 2, 2017.
NDA 208276 is the application under which FDA issued this complete response letter for REMODULIN to United Therapeutics Corporation. It was reviewed by FDA Other. The letter is dated June 2, 2017.
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.