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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Carton and Package Label Review - RECOTHROM

Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Case Management
Advertising and Promotional Labeling Branch


Date: November 14, 2007
To: Nisha Jain, M.D.,OBRR/DH/CRB (HFM-392)
Mark Shields, OBRR/ DBA/ RPM (HFM-370)
Through: Ele Ibarra-Pratt, R.N., M.P.H., Chief, APLB (HFM-602)
From: Maryann R. Gallagher, Consumer Safety Officer
Advertising and Promotional Labeling Branch (APLB)(HFM-602)
Subject: BLA STN 125248
ZymoGenetics, Inc.
Carton and package label review

ZymoGenetics, Inc. submitted revised labeling for THROMBIN TOPICAL (RECOMBINANT) on October 17, 2007.

APLB reviewed the revised proposed container and package labeling and we have no comments at this time.

If you have any questions, please call Maryann Gallagher, Consumer Safety Officer, and OCBQ/DCM/APLB at 301-827-6330.


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002