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
THROMBIN TOPICAL (RECOMBINANT)
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.