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