Product Approval Information - New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville MD 20852--1448
November 21, 2005
MacoProductions S.A.S.
Attention: P. Ann Hoppe
c/o Hoppe Regulatory Consultants
2335 Massey Lane
Decatur, GA 30033
Re: BN040083, Anticoagulant Citrate Phosphate Dextrose Solution (CPD) with Additive Solution (AS-1)/Leucoflex MTL1-WB Leukocyte Reduction System
Dear Ms. Hoppe:
Please refer to your new drug application dated October 28, 2004 and received November 8, 2004, submitted under section 505(b) pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for Anticoagulant Citrate Phosphate Dextrose Solution (CPD) with Additive Solution (AS-1)/Leucoflex MTL1-WB Leukocyte Reduction System, and the eight amendments received on January 12, February 2, March 28, April 26, May 12, June 1, September 20, and November 10, 2005.
We have completed our review of this application, as amended, and have concluded that adequate information has been presented to demonstrate that the Leucoflex MTL1-WB Leukocyte Reduction System is safe and effective for use for the pre-storage leukocyte reduction of whole blood initiated between 4 and 7 hours after collection if whole blood is stored at ambient temperature, or between 4 and 8 hours of storage at 1 to 6°C. The collection set provides for subsequent preparation of AS-1 Red Blood Cells Leukocytes Reduced and Plasma Leukocytes Reduced in a closed system. Accordingly, this application is approved effective on the date of this letter.
A 24-month dating period is granted to the Leucoflex MTL1-WB Leukocyte Reduction System containing the drug substances CPD and AS-1 solution based on the stability data submitted.
The final printed labeling (FPL) must be identical to the immediate container labels submitted on May 31, 2005. Marketing the products with FPL that is not identical to the approved labeling text may render the products misbranded and unapproved new drugs.
Please submit the final printed labeling (FPL) electronically according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format - NDA (January 1999) (http://www.fda.gov/cder/guidance/2353fnl.pdf). Alternatively, you may submit 20 paper copies of the FPL as soon as it is available but not more than 30 days after it is printed. Please individually mount ten of the copies on heavy-weight paper or similar material. For administrative purposes, this submission should be designated "FPL for approved NDA BN040083". Approval of this submission by FDA is not required before the labeling is used.
We remind you that you must comply with the requirements set forth under 21 CFR 314.80 and 314.81 for an approved NDA.
If you have any questions, contact Jeffrey Anderson, Regulatory Project Manager at (301) 827-3524.
Sincerely,
-- signature --
Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research