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 : 
  

  
EC3
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
06/27/2006 11:06:33
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 I oppose Safety or Efficacy for Diastat but also raise the issue of Safety for Strattera and ask for enforcement for a change. FDA has IND submissions when atomoxetine (renamed) ceased clinical investigations in the late 1980's. FDA is knowingly providing 'safe' after the fact, and oppose such. Labeling attached finally discloses to physicians a link to suicidality, only now disclosing depression data in a boxed warning, previously approved with depression data. FDA exempted Strattera originally from a Public Health Advisory on suicidality and in labeling. Others not approved for depression were required to disclose by that Advisory and were not approved for depression. Strattera has two public health advisories and FDA should withdraw the application and not provide 'Safety'. After the fact safety and efficacy is the fox watching the henhouse. 2 million prescriptions didn't get Medication Guides multiple advisories on a failed antidepressant. Don't allow Eli Lilly to purchase those. Strattera, because one FDA rejection wasn't enough on a tentatively approved SNRI.

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
2006P-0209-EC3-Attach-1.PDF