January 6, 2009 Approval Letter
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville MD 20852--1448
January 6, 2009
Gambro BCT, Inc.
Attention: Ms. Kathy Coressel
10811 West Collins Avenue
Lakewood, CO 80215
Dear Ms. Coressel:
Please refer to your abbreviated new drug application (ANDA) dated May 11, 2007 and received May 14, 2007, submitted under section 505(j)/pursuant to section 505(j)(2) of the Federal Food, Drug, and Cosmetic Act, for Anticoagulant Citrate Phosphate Dextrose Solution (CPD).
We acknowledge receipt of your submission dated July 16, 2008 and received July 17, 2008. Your submission of July 16, 2008 constituted a complete response to our December 21, 2007 Not Approvable letter.
We have completed our review of this application, as amended, and have concluded that adequate information has been presented to demonstrate that the drug product is safe and effective for use as recommended in the agreed upon labeling text. Accordingly, this application is approved effective on the date of this letter.
The final printed labeling (FPL) must be identical to the draft labeling submitted on December 02, 2008. Marketing the products with FPL that is not identical to the approved labeling text may render the product misbranded and an unapproved new drug.
Please submit the final printed labeling (FPL) electronically according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format - NDA. 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 ANDA BA070025." 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, please contact Heather Erdman, Regulatory Project Manager, at (301) 827-6182.
-- signature --
Jay Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research