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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resubmission Mid-Cycle Review - Isoplate Solution

FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
MEMORANDUM


 

 

From:               Yolanda Branch, Ph.D., Pharmacologist, CBER, OBRR, DH
 
To:                   Iliana Valencia, OBRR, DBA, RPMB
 
Through:          Iftekhar Mahmood, Ph.D., Team Lead, CBER, OBRR, DH
 
Subject:            Resubmission Mid-Cycle Review - Pharm/Tox Review of Isoplate (NDA BN090067/011), a platelet 
                        additive solution for the storage of leukoreduced hyperconcentrated platelets
 
Sponsor:           B. Braun Medical Inc.

 
There were no new preclinical studies submitted in NDA BN090067. All previous preclinical issues have been addressed (reference CRMTS #8012 and NDA BN090067/011).   This memorandum serves as the final review.