Issued to 3M Health Care (Infection Prevention Division). Application reviewed but not approved; deficiencies must be corrected.
Issued
May 6, 2016Application
NDA 505b1 • 208288
Product
SOLUPREP S
Company
3M Health Care (Infection Prevention Division)
Review center
Other
Stage
Final Decision
Response due
January 1, 2019
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 Clinical efficacy and substantial evidence, Chemistry, manufacturing, and controls, Bioequivalence and pharmacokinetics, Labeling, packaging, and proprietary name. 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 3M Health Care (Infection Prevention Division) on May 6, 2016.
NDA 208288 is the application under which FDA issued this complete response letter for SOLUPREP S to 3M Health Care (Infection Prevention Division). It was reviewed by FDA Other. The letter is dated May 6, 2016.
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.