
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. 