Vaccines, Blood & Biologics

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.

Indication for UseNDA NumberApplicantApproval Date
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
Isoplate Solution 
Indicated s a platelet additive solution for the storage of leukoreduced hyperconcentrated apheresis platelets. 
10811 W. Collins Ave
Lakewood, CO 80215-4440 



Page Last Updated: 06/03/2013
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