Filing Review Letter - SOLX® System
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
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.
Richard J. Davey, M.D.
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research