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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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

Hi Howard,

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.

Thank you,



Kelly Lewis
Regulatory Project Manager
Division of Blood Applications
Phone: 301 827 9427
Fax: 301 827 2858
email: kelly.lewis@fda.hhs.gov


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