
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

REVIEW MEMORANDUM

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)
 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.
