2005N-0345
  

  
 Drug Approvals:  Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product

  


  

  

  


  

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC11
  



  

  
Submitter : 
  

  
Mr. William Rivkin
  

  
Date & Time: 
  

  
09/01/2005 04:09:54
  



  

  
Organization : 
  

  
Mr. William Rivkin
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 This drug has been proven to be safe and effective. There is no scientific reason why it cannot sold over the counter. By playing politics with this drug the FDA is doing a great disservice to the American people.