Issued to Merck & Co., Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 28, 2013Application
NDA 505b1 • 204569
Product
BELSOMRA
Company
Merck & Co., Inc.
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, Statistical analysis. 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 Merck & Co., Inc. on June 28, 2013.
NDA 204569 is the application under which FDA issued this complete response letter for BELSOMRA to Merck & Co., Inc.. The letter is dated June 28, 2013.
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.