2006P-0001
  

  
Date of Approval for Lunesta (Eszopiclone) Tablets
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC4
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
02/02/2006 10:02:52
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I oppose the petition. This is marketed to consumers and swallowed as Lunesta, and there defeciencies in the last 3 pages. No patent, and an unapproved NDA. 



Attached is Lunesta, the drug product is called Estorra. The NDA patent according to USPTO is for Lunesta.



This is a predetermined outcome while approving a controlled substance in the Federal Register. Misbranded by false labeling, by being unapproved, patentless, violates CSA by not being classified and misbranded, and it's off to WHO for International classification. 



Some take 53 Lunesta for long term use once. Or Estorra depending.









  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
2006P-0001-EC4-Attach-1.PDF