2006P-0002
  

  
Methocarbamol Tablets USP, 1000 mg for Abbreviated new drug application (ANDA)
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Mr. Dave Lowe
  

  
Date & Time: 
  

  
02/02/2006 10:02:40
  



  

  
Organization : 
  

  
Mr. Dave Lowe
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 This is not suitable for a submission as an ANDA. The drug Robaxin is unapproved. It's NDA is #011011 and was approved in 1957. This was prior to legislation which mandates a drug show efficacy (i.e. clinical investigations). This drug has no valid patent, and is a threat to the public health. Remove Robaxin, and all drugs which reference this from the market, as it has never proven efficacy.



Labeling attached.

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
2006P-0002-EC1-Attach-1.PDF