Date: April 2, 2013
From: Xuan Chi, M.D., Ph.D.
Laboratory of Cellular Hematology
Through: Jaroslav Vostal, M.D., Ph.D.
Chief, Laboratory of Cellular Hematology
Division of Hematology/OBRR/CBER/FDA
To: Sonday Kelly, M.S.
Regulatory Project Manager
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.
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.
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.
All issues have been resolved and I recommend approval of BN110059.