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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2010 Biological License Application Approvals

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

Tradename/
Proper Name
Indication for Use STN Manufacturer/
License Number
Approval Date
GLASSIA Alpha1-Proteinase Inhibitor (Human)
 
Treatment of chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin. 125325/0

Kamada Ltd.
Beit Kama, 7 Sapir St
Kiryat Weitzmann, Science Park
P.O. Box 4081
Ness Ziona
74140 
Israel
License 1826
 

7/1/2010
ABBOTT PRISM Chagas
Trypanosoma cruzi (E. coli, Recombinant) Antigen
To screen individual human donors, including volunteer donors of whole blood and blood components and other living donors for the presence of antibodies to T. cruzi. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, in testing blood specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use in testing cord blood specimens. 125361/0

Abbott Labs
100 Abbott
Park Rd
D-49C, AP6C/2
Abbott Park, IL
60064
License 0043

 

4/30/2010
Provenge
Sipuleucel-T
Treatment of men with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

125197/0

 

Dendreon Corp
3005 First Ave
Seattle, WA
98121
License 1749
4/29/2010

TachoSil 
Fibrin Sealant Patch

 

Fibrin sealant patch indicated for use as an adjunct to hemostasis in cardiovascular surgery when control of bleeding by standard surgical techniques, such as suture, ligature or cautery, is ineffective or impractical. 125351/0 Nycomed
Danmark ApS
Langebjerg 1
DK-4000
Roskilde
Denmark
License 1825
4/5/2010
Fibrinogen (For Further Manufacturing Use) Fibrinogen (Human) active substance supplied by CSL Behring for further manufacturing of Fibrin Sealant Patch by Nycomed. 125356/0

CSL Behring GmbH
1020 First Ave
P.O. Box 61501
King of Prussia, PA

19406
License 1765

4/2/2010
Thrombin (Human) (For Further Manufacturing Use) Thrombin (Human) active substance supplied by CSL Behring for further manufacturing of Fibrin Sealant Patch by Nycomed. 125357/0 CSL Behring
GmbH
1020 First Ave
P.O. Box 61501
King of Prussia, PA 19406
License 1765
4/2/2010
Hizentra
Immune Globulin Subcutaneous (Human), 20% Liquid
Treatment of primary immunodeficiency (PI) 125350/0 CSL Behring AG
1020 First Ave.
P.O. Box 61501
King of Prussia, PA 19406-0901
License 1766
3/4/2010
Prevnar 13
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
For active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, for use in children 6 weeks through 5 years of age; For the prevention of otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F. 125324/0 Wyeth Pharmaceuticals, Inc
401 North Middleton Road
Pearl River, NY 10965
License 0003
2/24/2010
Menveo
Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
For active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 when administered to individuals 11 through 55 years of age. 125300/0 Novartis Vaccines and Diagnostics, Inc
4560 Horton St Emeryville, CA 94608-2916
License 1751
2/19/2010