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 : 
  

  
EC6
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
06/27/2006 11:06:03
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I oppose the petition Safety or Efficacy determiniations bear the  attached label. This is the same exact drug (Carbamazepine) as Tegretol, Tegretol XR, Shire's own Carbatrol and others after 30 years of waiting. Are there limits on approvals? Generic Tegretol three times a day or one extended release is enough. This is marketed with open label clinical investigations if anyone cares. That makes black boxes you see. It may be prescribed off label for many uses, but the clinical trials are not even close. Withdraw the labeled product attached for safety reasons, and count the carbamazepine. Please.

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
2006P-0209-EC6-Attach-1.PDF