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 : 
  

  
EC13
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
08/02/2006 11:08:46
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I oppose the peitition in whole. The current supplement in the Orange Book is inaccurate. I oppose the safety and efficacy of Abilify. One cannot marketing off label (bipolar disorder), and without scientific TE, or RLD's. See PDF of the website and the Orange Book. Misbrand Abilify and withdraw any paper NDA's and Fed Reg determinations that may or may not be approving such legally for BMS.

  


  

  


  

  


  

  



  

  
2006P-0209-EC13-Attach-1.PDF