Product Approval Information
Our STN: BL 125266/0
Baxter Healthcare Corporation
Attention: Mr. Brian L. Bishop
One Baxter Way
Westlake Village, CA 91362-3811
Dear Mr. Bishop:
We have received your biologics license application (BLA) submitted under section 351 of the Public Health Service Act for the following biological product:
Our Submission Tracking Number (STN): BL 125266/0
Name of Biological Product: Fibrin Sealant
Indication: Fibrin Sealant (FS VH S/D 4, frozen and lyophilized) for adhering autologous skin grafts to surgically prepared wound beds resulting from burns in adults and pediatric populations.
Date of Application: May 31, 2007
Date of Receipt: June 1, 2007
Action Due Date: March 31, 2008
All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We note that you have submitted pediatric studies with this application. Once the review of this application is complete we will notify you whether you have fulfilled the pediatric study requirement for this application.
We request that you submit all future correspondence, supporting data, or labeling relating to this application in triplicate, citing the above STN number. Send all correspondence to the following address:
Director, Division of Blood Application, HFM-370
DCC, Suite 200N, HFM-99
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
We will notify you within 60 days of the receipt date if the application is sufficiently complete to permit a substantive review.
If you have any questions, please contact me at (301) 827-6124.
Sincerely yours,
/Pratibha Rana, M.S./
Pratibha Rana, M.S.
Regulatory Project Manager
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research