Issued to TherapeuticsMD, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 5, 2017Application
NDA 505b1 • 208564
Product
IMVEXXY
Company
TherapeuticsMD, Inc.
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 Safety and adverse events, Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence. 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 TherapeuticsMD, Inc. on May 5, 2017.
NDA 208564 is the application under which FDA issued this complete response letter for IMVEXXY to TherapeuticsMD, Inc.. It was reviewed by FDA Other. The letter is dated May 5, 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.