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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2013 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals

This list reflects information regarding the applications as of the approval date.  It is not updated with regard to applicant or application status changes.

Tradename
 
Indication for UseNDA NumberApplicantApproval Date
LEUKOSEP® HWB-600-XL
Leukocyte Reduction Filtration
System for Whole Blood with CPD Anticoagulant and SOLX® Additive 

 
For collection and processing of one unit CPD WB to manufacture one unit AS-7 RBC and one unit FFP 
 
BN110059 Hemerus Medical, LLC
5000 Township Parkway
Saint Paul, MN 55110
4/25/2013
Isoplate Solution 
 
Indicated s a platelet additive solution for the storage of leukoreduced hyperconcentrated apheresis platelets. 
 
BN090067 TERUMO BCT
10811 W. Collins Ave
Lakewood, CO 80215-4440 
 
3/5/2013