2006P-0397
  

  
Permit an ANDA Suitability for Fexofenadine Hydrochloride for Oral Suspension
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
10/05/2006 09:10:55
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 No fexofenadine based products (See Orange Book search attached) clinically demonstrate safety and/or efficacy. I oppose the petition, and support withdrawing all applications.

  


  

  


  

  



  

  
2006P-0397-EC1-Attach-1.PDF