2006P-0001
  

  
Date of Approval for Lunesta (Eszopiclone) Tablets
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
02/02/2006 10:02:42
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 It would help if the petition was available for viewing on 1/05. Lawyers would like to know the date of approval to be consumed. Marketed to consumers giving away 'controlled substances' and FDA approved for long term use, if you believe TV.

If the sponsor has any questions until information is available on a misbranded drug, the sponsor should call the Regulatory Project Manager.

Website labeling attached.

  


  

  


  

  


  

  


  

  



  

  
2006P-0001-EC1-Attach-1.PDF