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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2011 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 UseSTNManufacturer/
License Number
Approval Date
Hemacord
Hematopoietic Progenitor Cells, Cord (HPC-C) 
Minimally manipulated,
unrelated allogeneic placental/umbilical hematopoietic progenitor cells (HPC-C)
125397/0New York Blood Center, Inc.
310 East 67th Street
New York, NY 10021
License 0465
11/10/2011
 
ULTRAQUAL HBV PCR Assay
Hepatitis B Virus (Hepatitis B
Virus/Nucleic Acid Pooled Testing/Synthetic) 
For the qualitative detection of HBV DNA in individual orpooled samples of human Source Plasma (or plasma samples obtained from Source Plasma donors at the time of donation). 125193/0National Genetics Institute
2311 Pontius Avenue
Los Angeles, CA  90064
License 1582 
9/1/2011
Source Plasma  New manufacturer of source plasma. 125316/0Upstate New York Transplant Services, Inc.
110 Broadway
Buffalo, NY 14203
License 1805 
 
8/18/2011
 
Source PlasmaNew manufacturer of source plasma.125362/0ADMA Bio Centers Georgia, Inc.
6290 Jimmy Carter Blvd Suite 208
Norcross, GA  30071
License 1834 
8/12/2011
Anascorp
Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection
Treatment of clinical signs of
scorpion envenomation.
125335/0Rare Disease Therapeutics, Inc. (RDT)
2550 Meridian Blvd Suite 150
Franklin, TN
License 1860
8/3/2011
Spherusol
Coccidioides immitis Spherule-Derived Skin Test Antigen
For the detection of delayed type hypersensitivity to C. immitis in individuals, 18-64 years of age, with a history of pulmonary coccidioidomy-cosis.125354/0Allermed Laboratories, Inc.
7203 Convoy Court
San Diego, CA  92111
License 0467
7/29/2011
Azficel-T
For the improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.
125348/0
Fibrocell Technologies, Inc.
405 Easleview Blvd.
Exton, PA 19341
License 1818
6/21/2011
KEDBUMIN
Albumin (Human)
 
  • Hypovolemic shock
  • Hypoalbuminemia
  • Prevention of central volume depletion after paracentesis due to cirrhotic ascites
  • Ovarian Hyperstimulation Syndrome (OHSS)
  •  Adult Respiratory Distress Syndrome (ARDS)
  • Burns
  • Hemodialysis patients undergoing long term dialysis
  • Patients who cannot tolerate substantial volumes of salt solution
  • Priming solution for cardiopulmonary bypass
125384/0Kedrion, S.p.A.
Via Provinciale Loc. Bolognana, Italy
License 1851
 
6/3/2011
Adenovirus Vaccine Live
Oral Type 4 and Type 7
  
Active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, is approved for use in military populations 17 through 50 years of age.125296/0Teva Women's Health, Inc.
425 Privet Road
P.O. Box 1005
Horsham, PA 19044
License 1804
3/16/2011
Corifact
Factor XIII Concentrate (Human)
 
Routine prophylactic treatment of congenital factor XIII deficiency.125385/0

CSL Behring GmbH
1020 First Ave
King of Prussia, PA 19406-0901
License 1765 

2/17/2011