Final CMC Review Memo - ARTISS

M E M O R A N D U M
 Department of Health and Human Services
 Public Health Service
 Food and Drug Administration
 Center for Biologics Evaluation and Research

March 3, 2008 

To: The File of STN 125266/0 and Pratibha Rana, OBRR/DBA/RPMB 

From: Laura Wood, Committee Chair, OBRR/DH/LH 

Subject: Final CMC Review Memo for Original BLA 125266.0 for Fibrin sealant VH/SD 4 (Human) with 4 IU Thrombin from Baxter Healthcare Corporation, Baxter Bioscience. 

Through:  Timothy Lee, Ph.D., Acting Lab Chief, OBRR/DH/LH 

Review Committee: Paul Buehler (Pharm/Tox)
 Joseph D. Doleski (DMPQ)
 Maryann Gallagher (APLB)
 Kimberly Lindsey (Clinical)
 Iftehkar Mahmood (PK)
 Pratibha Rana (RPM)
 Robert Wesley (BiMo)
 Boris Zaslavsky (Statistical) 


Background

Baxter Healthcare Corporation, Baxter Bioscience has submitted an original BLA 125266.0 to support safety and efficacy of Fibrin sealant VH S/D with 4 IU thrombin for clinical use in adhering autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations. Fibrin Sealant VH S/D 4 (FS VH S/D 4) [ARTISS®] is a parallel development to TISSEEL® Fibrin Sealant (BL 103980). Except for the difference in thrombin concentration (4 IU/ml vs. 500 IU/ml), the manufacturing process for Fibrin Sealant VH S/D 4 is ------------------

CMC Review

--------------------
 ---------------
 ------------------------------------
 -----------------------------------------------

------------- ---------------------------------
 -------------------------------------------------------------
 -----------------------------------------------------------------------
 -----------------------------------------------------------------

------------------------------------------------------------------------
 -------------------------------------------------------------------------------------
 ----------------------------------------------------------------------------

33 PAGES

REDACTED
 

 
 