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Filing Review Letter - SOLX® System




  
 
DEPARTMENT OF HEALTH & HUMAN SERVICES                                            
         Public Health Service
 


                                                                                 
                                           Food and Drug Administration

1401 Rockville Pike

Rockville, MD 20852-1448

 

Our STN:  BN110059/0

Hemerus Medical, LLC
Attention:  Ms. Lynn Jensen
5000 Township Parkway 
Saint Paul, MN  55110

Dear Ms. Jensen:

Please refer to your New Drug Application (NDA) dated October 28, 2011, 
submitted November 1, 2011, submitted under Section 505(b) of the Federal Food, 
Drug, and Cosmetic Act (FDCA or the Act) for HEMERUS LEUKOSEP® HWB-600-XL 
Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and 
SOLX® Additive.

We also refer to your amendments dated November 9, 2011; November 15, 2011; 
November 18, 2011; December 7, 2011; December 9, 2011; and December 12, 2011.

We have completed our filing review and have determined that your application is 
sufficiently complete to permit a substantive review.  Therefore, in accordance 
with 21 CFR 314.101(a), this application is considered filed 60 days after the 
date we received your application.  The review classification for this 
application is Standard.  Therefore, the goal date is September 1, 2012.

We are reviewing your application according to the processes described in the 
Guidance for Review Staff and Industry: Good Review Management Principles and 
Practices for PDUFA Products.  Therefore, we have established internal review 
timelines as described in the guidance, which includes the timeframes for FDA 
internal milestone meetings (e.g., filing, planning, midcycle, team and wrap-up 
meetings).  Please be aware that the timelines described in the guidance are 
flexible and subject to change based on workload and other potential review 
issues (e.g., submission of amendments).  We will inform you of any necessary 
information requests or status updates following the milestone meetings or at 
other times, as needed, during the process. If major deficiencies are not 
identified during the review, we plan to communicate proposed labeling and, if 
necessary, any postmarketing commitment requests by July 5, 2012.

At this time, we are notifying you that, we have not identified any potential 
review issues.  Please note that our filing review is only a preliminary 
evaluation of the application and is not indicative of deficiencies that may be 
identified during our review.

Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all 
applications for new active ingredients, new indications, new dosage forms, new 
dosing regimens, or new routes of administration are required to contain an 
assessment of the safety and effectiveness of the product for the claimed 
indication(s) in pediatric patients unless this requirement is waived, deferred, 
or inapplicable.

Because none of these criteria apply to your application, you are exempt from 
this requirement.

If you have any questions, call Sonday L. Kelly, M.S., Regulatory Project 
Manager at (301) 827-6122.

Sincerely yours,

/s/

Richard J. Davey, M.D.
Director
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics 
Evaluation and Research 
 
 

    
 