Issued to Dow Pharmaceutical Sciences, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 15, 2018Application
NDA 505b1 • 209354
Product
DUOBRII
Company
Dow Pharmaceutical Sciences, Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2020
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence, Bioequivalence and pharmacokinetics, 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.
Open the document workspaceFDA source document
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Dow Pharmaceutical Sciences, Inc. on June 15, 2018.
NDA 209354 is the application under which FDA issued this complete response letter for DUOBRII to Dow Pharmaceutical Sciences, Inc.. It was reviewed by FDA Other. The letter is dated June 15, 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.