
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. 