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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2005 Biological License Application Supplement Approvals

This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed by date of approval.


Note: Approvals are listed with the most recent action at the top.

Tradename/
Proper Name
Indication for UseSTNManufacturer/
License No.
Approval Date
Package Insert Revision:
Include addition of clinical safety information to the package insert
125106/10GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617
12/29/2005
Package Insert Revision125089/47Aventis Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277
10/21/2005
Package Insert Revision:
To support lowering the age indication for Havrix from two years to 12 months of age
103475/5090GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617
10/17/2005
Package Insert Revision:
Include a new Black Box warning for cardiac events and other safety information
101106/5067Wyeth Pharmaceuticals, Inc
401 North Middleton Road
Pearl River, NY 10965-8668
License 0003
10/11/2005
New Dosage Form:
Addition of a preservative free single dose vial formulation
103913/ 5047Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277
9/23/2005
New Formulation:
2005-2006 United States formulation
103837/5066Chiron Vaccines Ltd
Gaskill Road
L249GR
Speke, Liverpool UK
License 1720
9/14/2005
Manufacturing Change:
---- Fr.IV1+4 paste as an alternate starting material
125039/69Baxter Healthcare Corp
One Baxter Way
Westlake Village, CA 91362
License 0140
9/9/2005
New Formulation:
2005-2006 United States formulation
125020/69MedImmune Vaccines, Inc
297 N. Bernardo Ave
Mountain View, CA 94043
License 1652
8/18/2005
Expanded Indication for Use:
For use in surgical procedures in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
103665/5057Novo Nordisk Pharmaceuticals, Inc
100 College Road West
Princeton, NJ 08540
License 1261
8/12/2005
Expanded Indication for Use:
Lowering the age indication for VAQTA from two years to 12 months of age
103606/5049Merck & Co, Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002
8/11/2005
Expanded Indication for Use:
Testing for Hepatitis B Virus DNA in post-mortem cadaveric (non-heart-beating) donors using an individual testing format
125090/3Roche Molecular Systems, Inc
4300 Hacienda Drive
Pleasanton, California 94566-0900
License 1636
8/2/2005
Manufacturing Change:
Include modification to the manufacturing process and creation of new Reverse-Cyte A1 and B cells and Search-Cyte Pool, Duo and Trio Reagent Red Blood Cell products for use on the TANGO Automated Blood Bank Analyzer
103898/5019Medion Diagnostics GmbH
Bonnstrasse 9
CH-3186 Dudingen
Switzerland
License 1616
7/26/2005
New Formulation:
Include a preservative free single dose presentation in a unit dose vial
103914/5097Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277
7/14/2005
New Formulation
Include the 2005-2006 United States formulation
103914/5101Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277
7/14/2005
New Indication for Use:
Treatment of bleeding episodes in patients with Factor VII Deficiency
103665/5052Novo Nordisk Pharmaceuticals, Inc
100 College Road West
Princeton, NJ 08540
License 1261
7/11/2005
Diphtheria and Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use)
For further manufacture to Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed under a shared manufacturing arrangement with GlaxoSmithKline Biologicals103648/5046Chiron Behring GmbH & Co
P.O. Box 1630
35006 Marburg
Germany
License 1222
5/3/2005
Extension of dating to 36 months103821/5070BioPort Corp
3500 N. Martin Luther King, Jr. Blvd
Lansing, MI 48906
License 1260
4/27/2005
Optional second dose for children 12 months to 12 years of age103552/5079Merck & Co, Inc
Sumneytown Pike
P.O. Box 4
West Point, PA 19486
License 0002
4/5/2005
New Formulation:
Provide for a liquid formulation
103649/5107Cangene Corp
104 Chancellor Matheson Rd
Winnepeg, Manitoba
Canada R3T5Y3
License 1201
3/31/2005
Package Insert Revision
Changes to the previously approved 2004-2005 US labeling (package insert)
125020/44MedImmune Vaccines, Inc
297 N. Bernardo Ave
Mountain View, CA
License 1652
3/18/2005
Expanded Indication for Use:
Testing of individual cadaveric specimens (obtained from non-heart-beating donors)
125045/5015Roche Molecular Systems
4300 Hacienda Drive
PO Box 9002
Pleasanton, CA 94566-0900
License 1636
3/9/2005
Expanded Indication for Use
Testing of individual cadaveric specimens (obtained from non-heart-beating donors)
125059/13Roche Molecular Systems
4300 Hacienda Drive
PO Box 9002
Pleasanton, CA 94566-0900
License 1636
3/9/2005