Resubmission Mid-Cycle Review - Isoplate Solution
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
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.