Issued to Scilex Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 10, 2016Application
NDA 505b1 • 207962
Product
ZTLIDO
Company
Scilex Pharmaceuticals, 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 Safety and adverse events, Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Nonclinical 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 Scilex Pharmaceuticals, Inc. on May 10, 2016.
NDA 207962 is the application under which FDA issued this complete response letter for ZTLIDO to Scilex Pharmaceuticals, Inc.. It was reviewed by FDA Other. The letter is dated May 10, 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.