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Mid Cycle Review Memo, April 2, 2013 - SOLX® System




 
Date:              April 2, 2013

From:             Xuan Chi, M.D., Ph.D.
Lead reviewer 
Laboratory of Cellular Hematology
DH/OBRR/CBER/FDA
(301)-827-2008

Through:      Jaroslav Vostal, M.D., Ph.D.
Chief, Laboratory of Cellular Hematology
Division of Hematology/OBRR/CBER/FDA
(301)-827-9655

To:                  Sonday Kelly, M.S.
Regulatory Project Manager
CBER/OBRR/DBA
(301)-827-6122

Subject:         Review of Hemerus’ response to FDA CR letter (Class I 
resubmission)
Original Submission #: NDA BN110059
Product:         The LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System 
for Whole Blood with CPD Anticoagulant and SOLX® Additive also called “SOLX® 
System”.

Revised Indications for Use:

The LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood 
with CPD Anticoagulant and SOLX® Additive also called “SOLX® System” is intended 
for the manufacture of:
• CPD/AS-7 Red Blood Cells (RBC), Leukocytes Reduced prepared at ambient 
temperature and, placed at 1 to 6° C within 8 hours of collection. CPD/AS-7 Red 
Blood Cells, Leukocytes Reduced may be stored at 1 to 6° C for up to 42 days 
after collection.
• Fresh Frozen Plasma (FFP), Leukocytes Reduced prepared and placed in a freezer 
at -18° C or colder within 8 hours of collection. Fresh Frozen Plasma (FFP), 
Leukocytes Reduced may be stored at -18° C or colder for up to one year after 
collection.

Introduction:  
1. HEMERUS Medical, LLC submitted an original NDA for the HEMERUS LEUKOSEP 
HWB-600-XL Leukocyte Reduction Filtration System for the Whole Blood with CPD 
anticoagulant and SOLX additive solutions (also called SOLX System). It is 
designed with an integrated donor needle, blood diversion bag with integrated 
blood sampling port, whole
blood collection bag, LEUKOSEP® leukoreduction filter, red blood cell storage 
bag,
plasma storage bag and SOLX® additive solution bags. SOLX additive solution is a 
new red blood cell additive solution.
2. A CR letter was issued on August 31, 2012.
3. Hemerus submitted Amendment A15 on February 26, 2013, intended to address all 
concerns outlined in the FDA complete response letter.

Review Summary:
Reviewers’ questions on toxicology, sterilization, transportation studies and 
labeling have been addressed satisfactorily.
  For toxicology review, please see mid-cycle review memo from M.Keith Wyatt and 
  Xuan Chi.
  For review on clinical studies, please see mid-cycle review memo from Xuan Chi 
  and final review memo from Ping He.
  For review on sterilization and transportation studies, please see final 
  review memo from Ellen Huang.
  For labeling review, please see final review memo from Lore Fields.

Letter-ready comments: 
None

Recommendations:
All issues have been resolved and I recommend approval of BN110059.

 
 