2006P-0144
  

  
 delalutin hydroxyprogesterone caproate) Injection was not withdrawn for safety or effectiveness reasons and therefore suibable for ANDA

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2
  



  

  
Submitter : 
  

  
Mr. Seth McLaughlin
  

  
Date & Time: 
  

  
06/13/2006 02:06:25
  



  

  
Organization : 
  

  
Mac's Medicine Mart, Inc.
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Our community has suffered due to lack of availability of this drug. Many high risk mothers who suffered through multiple miscarriages were able to come to term because a local doctor used novel therapies including hydroxyprogesterone caproate. Those mothers are now left with few choices.