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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Memo - Octaplas

 

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
 
 
To:                      File of STN 125416_0 and Pratibha Rana                   
 
From:                 Nancy Kirschbaum, PhD, BLA Chair                          
 
Subject:              Filing Memo: Original BLA for OctaplasLG™, pooled plasma (human), solvent detergent treated, STN 125416_0
 
Through:            Tim Lee, Acting Chief, Laboratory of Hemostasis/DH/OBRR
 
CC:                     Review committee members: Mikhail Ovanesov, Ze Peng, M. Keith Wyatt, Harold Boxenbaum, Mitchell Frost, Jie He, Michael Brony, Christine Drabick, Jerald Mullersman, Renee Rees
                                                                       
 
Background
Octapharma Pharmazeutika, GmbH (Octapharma) has submitted original biologics license application (BLA), STN 125416_0 to support market clearance in the US for OctaplasLG™, pooled plasma (human), solvent detergent treated.
 
Octapharma seeks to obtain a clinical indication for management of pre-operative or bleeding patients who require replacement of multiple plasma coagulation factors and the substitution of intentionally removed plasma (e.g. plasma exchange in patients with thrombotic thrombocytopenic purpura – TTP).
 
OctaplasLG™ will be manufactured at the following locations:
Octapharma AB
S-112 75
Stockholm, Sweden
 
Octapharma Pharmazeutika Produktionsges.m.b.H
Oberlaaer Strasse 235
A-1100 Vienna, Austria
 
Filing Recommendation
Based on preliminary review of STN 125416_0 by all committee members, this original BLA for OctaplasLG™, pooled plasma (human), solvent detergent treated may be filed.