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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Labeling Meeting Summary - May 5 2009 and May 8, 2009

MEETING DATES: May 5, 2009 and May 8, 2009.

FROM:                       Debbie Cordaro

RE:                             Labeling Meeting Summary for STN: 125329/0

ATTENDEES:          Hon-Sum Ko, Dorothy Scott, Michael Kennedy, Malgorzata Mikoajczyk, Ann Gaines, Craig Zinderman, Xue Lin, Lisa Stockbridge and Debbie Cordaro

FIRM:                                    BPL                

PRODUCT:               Immune Globulin Intravenous (Human)

TO:     File

During the meetings held on May 5 and 8, 2009, the committee revised the package insert that resulted in the first revision submitted to the firm on July 16, 2009.