Reference: NDA BN110059
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, received November 1, 2012, submitted under Section 505(b) of the Federal Food, Drug, and Cosmetic Act, for SOLX® System, LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and SOLX® Additive, 70 mL CPD and 110 mL SOLX® Additive.
We acknowledge receipt of your amendments dated November 9, 2011; November 15, 2011; November 18, 2011; December 7, 2011; December 9, 2011; December 12, 2011; January 4, 2012; January 11, 2012; March 7, 2012; May 2, 2012; May 17, 2012; June 6, 2012; July 12, 2012; July 17, 2012; July 20, 2012; July 26, 2012; December 14, 2012; February 26, 2013; March 22, 2013; and April 3, 2013.
The February 26, 2013, submission constituted a complete response to our August 31, 2012, action letter.
This NDA provides for the use of SOLX® System for collection and processing of one unit CPD WB to manufacture one unit AS-7 RBC and one unit FFP; AS-7 RBC may be stored for up to 42 days after collection.
We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
CONTENT OF LABELING
As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA automated drug registration and listing system (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
Content of labeling must be identical to the enclosed labeling text for the package insert.
Information on submitting SPL files using eLIST may be found in the guidance for industry SPL Standard for Content of Labeling Technical Qs and As, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072392.pdf.
The SPL will be accessible via publicly available labeling repositories.
Your application for SOLX® System was not referred to an FDA advisory committee because this drug is not the first in its class and all ingredients of the CPD and AS-7 solutions have been previously approved for use in other anticoagulant and red cell additive solutions. In addition, the safety profile is similar to that of other drugs approved for this indication.
REQUIRED PEDIATRIC ASSESSMENTS
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.
You may request advisory comments on proposed introductory advertising and promotional labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the proposed materials in draft or mock-up form with annotated references, and the package insert to:
Food and Drug Administration
Center for Biologics Evaluation and Research
Advertising and Promotional Labeling Branch, HFM-602
1401 Rockville Pike
Rockville, MD 20852-1448
As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the package insert, at the time of initial dissemination or publication, accompanied by a Form FDA 2253. For instruction on completing the Form FDA 2253, see page 2 of the Form. For more information about submission of promotional materials to the Office of Prescription Drug Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81).
If you have any questions, please call Sonday L. Kelly, MS, RAC, Regulatory Project Manager, at (301) 827-6162.
Jay S. Epstein, MD
Office of Blood Research and Review
Center for Biologics
Evaluation and Research
Content of Labeling