Issued to Trevena, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
November 2, 2018Application
NDA 505b1 • 210730
Product
OLINVYK
Company
Trevena, Inc.
Review center
Other
Stage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Clinical efficacy and substantial evidence, Bioequivalence and pharmacokinetics. 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 Trevena, Inc. on November 2, 2018.
NDA 210730 is the application under which FDA issued this complete response letter for OLINVYK to Trevena, Inc.. It was reviewed by FDA Other. The letter is dated November 2, 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.