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 : 
  

  
EC15
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
08/03/2006 04:08:31
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 A quick review misbrands the Doxil label and FDA should withdraw any documents making that approval legal if they exist. The label is bizarre, but urge careful review as an FDA sanctioned label for safety and efficacy. I oppose the petition.

  


  

  


  

  



  

  
2006P-0209-EC15-Attach-1.PDF