2006P-0209
  

  
 Safety or Efficacy of Diastat (diazepam rectal gel), 5 mg/ml, 10mg/2 ml, 15 mg/3 ml and 20 mg/4 ml

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC8
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
07/10/2006 08:07:17
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I oppose the petition. Enforcement is needed. I included the Lexapro label. escitalopam added an oxylate, and PK parameters alone misbrand Lexapro. Withdraw any paper NDA's.

  


  

  


  

  



  

  
2006P-0209-EC8-Attach-1.PDF