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Vaccines, Blood & Biologics

Statistical Review and Evaluation - Intersol


Statistical Review and Evaluation



Date of the review:11/12/09
Type of submission:BN_080041
Product/Application:InterSol Solution for storage of AMICUS-Derived Apheresis Platelets.
Indication: The InterSol Solution is a plasma replacement fluid for storage of platelet using routine blood banking conditions. Platelet products stored in InterSol are transfused to patients with low platelet counts or to decrease bleeding.
Sponsor:Fenwal Inc.
From:Tie-Hua Ng, Ph.D.
Through:Ghanshyam Gupta, Ph.D.,Branch Chief, Therapeutics Evaluation Branch (HFM-219)
To:Salim Haddad, Medical officer
Heather Erdman, Regulatory Project manager

cc: HFM-219/ Paul Hshieh
HFM-219/ Ghanshyam Gupta
HFM-215/ Henry Hsu
HFM-215/ Christopher Egelebo

Executive Summary

There are no outstanding statistical issues for this NDA.


The statistical review of the original NDA was completed by Paul Hshieh (March 20, 2009). Subsequently, the sponsor responded to (i) the FDA’s CR (complete response) letter dated April 6, 2009 and (ii) IR (information request) that were faxed on July 28, 2009 and September 18, 2009 in the submissions dated May 13, 2009, August 7, 2009 and September 22, 2009 2009, respectively. The reviews of these responses were also done by Paul Hshieh. However, only two written review memos were done (July 27, 2009 and August 24, 2009) for the reviews of the first two submissions. Nevertheless, Paul Hshieh has indicated in his email dated October 1, 2009 that the sponsor’s responses on September 22, 2009 are acceptable. As Paul Hshieh is on leave, I completed this final review memo.

Statistical Evaluation

To my knowledge, there are no outstanding statistical issues for this NDA.

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