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2005P-0423: Immediately Add a Black Box Warning Regarding the Risks of Drug-induced Blindness for the Three Phosphodiesterase 5 Inhibitors that are Prescribed for the Treatment of Erectile Dysfuntion

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
CP1 10/20/2005 10/20/2005 Consumer Group Public Citzen's Health Research Group       pdf  
Signature: Elizabeth Barbehenn, Ph.D. et. al.
ACK1 10/20/2005 10/20/2005 Federal Government HFA-305 to Public Citzen's Health Research Group       pdf  
Signature: Lyle D. Jaffe
EC1 10/27/2005 10/22/2005 Health Care Association IRB       htm  
  Signature: Wolberg, Rev Richard
EC2 10/27/2005 10/26/2005 Individual Consumer Mr. Peter Iano       htm  
EC3 12/19/2005 12/14/2005 Individual Consumer Ms. Irene Ferraiuolo       htm  
LET1 04/19/2006 04/19/2006 Federal Government HFD-005 to Public Citizen's Health Research Group       pdf  
  Signature: Jane A. Axelrad
C1 05/22/2006 05/17/2006 Individual Consumer D. Lowe          
C2 06/07/2006 06/06/2006 Drug Industry Pfizer, Inc.       pdf  
Signature: Cathryn M. Clary, MD
LET2 06/07/2006 06/06/2006 Drug Industry Pfizer, Inc.       pdf  
Signature: Richard Siegel, M.D.

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