Info Request PNR Issue - July 21, 2009
From: Lewis, Kelly R
Sent: Tuesday, July 21, 2009 3:38 PM
To: 'Smith, Howard'
Subject: BLA STN 125329/0 tradename
Here is an information request question regarding the tradename:
"Please justify your tradename "Gammaplex" by providing information on any other drug/biologic having the suffix "-plex". We note that there is a potential confusion leading people to believe the product to be among the Prothrombin Complex Concentrates (PCCs), such as Autoplex T, Beriplex P/N or Octaplex."
Please respond as soon as possible.
Regulatory Project Manager
Division of Blood Applications
Phone: 301 827 9427
Fax: 301 827 2858
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