2006P-0001
  

  
Date of Approval for Lunesta (Eszopiclone) Tablets
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC3
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
02/02/2006 10:02:23
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 A previous comment regarding patents did not imply approval of this petition. Lunesta is a marketed product, and according to DEA's docket it was classified as a CIV while unapproved. This was marketed before HHS could recommend scheduling and oppose Docket 2006P-0001.



Remove Lunesta from the market as an unapproved drug.