Issued to ELC Group. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 29, 2015Application
NDA 505b1 • 205054
Product
LEUPROLIDE ACETATE FOR DEPOT SUSPENSION
Company
ELC Group
Review center
Other
Stage
Final Decision
Response due
November 13, 2026
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Clinical efficacy and substantial evidence, Safety and adverse events. 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 ELC Group on May 29, 2015.
NDA 205054 is the application under which FDA issued this complete response letter for LEUPROLIDE ACETATE FOR DEPOT SUSPENSION to ELC Group. It was reviewed by FDA Other. The letter is dated May 29, 2015.
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.