c/o Carolina Research Group, Inc.
Attention: W. Gerald Coln
P.O. Box 32295
Raleigh NC 27622-2295
Dear Mr. Coln:
We have received your new drug application (NDA) submitted under section 505(b) of the Federal Food, Drug and Cosmetic Act for the following:
Name of Drug Product: Voluven
Date of Application: 28-FEB-07
Date of Receipt: 01-MAR-07
Submission Tracking Number: BN070012
Unless we notify you within 60 days of the receipt date that the application is not sufficiently complete to permit a substantive review, this application will be filed under section 505(b) of the Act on the date sixty days from the date of receipt of application in accordance with 21 CFR 314.101(a).
Please cite the NDA number listed above at the top of the first page of any communications concerning this application.
If you have further questions, I may be reached at (301) 827-6161.
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research