Vaccines, Blood & Biologics
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
| Date: | 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
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33 PAGES
