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  1. Vaccines, Blood & Biologics

2016 Biological License Application Approvals

2016 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.

2016 Biological License Application Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License Number
Approval Date
MACI
autologous cultured chondrocytes on porcine collagen membrane
MACI™ is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults 125603/0 Vericel Corporation
55 Cambridge Parkway,
Cambridge, MA, 02142

Lic. # 2010
12/13/2016
cobas® WNV
West Nile Virus Nucleic acid test for use in the cobas 6800/8800 Systems
cobas® WNV is indicated for qualitative in vitro nucleic acid screening test for the direct detection of West Nile Virus (WNV) RNA in human plasma. 125575/0 Roche Molecular Systems, Inc.
4300 Hacienda Dr,
Pleasanton, CA, 94588-2722

Lic. # 1636
11/2/2016

IH-Card ABO D(DVI+)+Rev A1B;
 IH-Card ABO D(DVI-)+Rev A1B;
 IH-Card ABD(DVI-)-Conf;
IH-Card ABO;
 IH-Card ABO RhD(DVI+);
IH-Card ABD(DVI+)-Conf

Blood Grouping Reagent, Anti-B (Murine Monoclonal) (IgG)(Formulated for Automated Testing)

Blood Grouping Reagent, Anti-B (Murine Monoclonal) (IgG) (Formulated for Automated Testing) is intended for use in IH-Card BGR products.

The IH-Card products are intended to be used on the IH-1000 Analyzer system for blood grouping and antigen typing of human red blood samples using the hemagglutination and gel filtration technique
125532/0

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich
Germany

Lic. # 1845
10/21/2016

Anti-Human Globulin Anti-IgG,-C3d; Polyspecific IH-Card AHG Anti-IgG,-C3d

Anti-Human Globulin (Rabbit/Murine Monoclonal) (Formulated for Automated Testing)

The Anti-Human Globulin (Rabbit/Murine Monoclonal) (Formulated for Automated Testing) is indicated for use in IH-Cards AHG Anti-IgG, -C3d product is detection of antibodies and complement on human red blood cells using Direct and Indirect Antiglobulin Tests on the IH Analyzer System.

 125529/0

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich
Germany

Lic. # 1845
10/21/2016

IH-Anit-D (RH1) Blend

Blood Grouping Reagent, Anti-D (Monoclonal Blend)(Formulated for Automated Testing)

It is intended to be used with the IH-Card AHG Anti-IgG for testing weak and partial D antigens (including DVI) in Low Saline Solution (LISS)-Indirect Antiglobulin Test (IAT) on the IH-1000 Analyser System. 125533/0

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich
Germany

Lic. # 1845

10/21/2016

Cell Line: ESD1M

Blood Grouping Reagent, Anti-D (Human/Murine Heterohybridoma) (For Further Manufacturing Use)

The Blood Grouping Reagents (For Further Manufacturing Use) are indicated for use in the manufacture of in vitro product Blood Grouping Reagents, Anti-D by Bio-Rad Medical Diagnostics (BMD) GmbH U.S. License No. 1845 under a shared manufacturing agreement for further manufacturing into final get card products for use on the IH-1000 System.

125550/0

Alba Bioscience Limited

Ellen's Glen Road, Edinburgh EH17 7QT
United Kingdom

Lic. # 1807

10/21/2016

Cell Line: DEM1

Blood Grouping Reagent, Anti-E (Human/Murine Monoclonal)(For Further Manufacturing Use)
The Blood Grouping Reagents (For Further Manufacturing Use) are indicated for use in the manufacture of in vitro product Blood Grouping Reagents, Anti-E by Bio-Rad Medical Diagnostics (BMD) GmbH U.S. License No. 1845 under a shared manufacturing agreement for further manufacturing into final get card products for use on the IH-1000 System. 125551/0

Alba Bioscience Limited

Ellen's Glen Road, Edinburgh EH17 7QT
United Kingdom

Lic. # 1807

10/21/2016

cobas® MPX

HIV-1 Group O and M, HIV-2, HCV and/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT/pool testing)

It’s indicated for qualitative in vitro nucleic acid test for the direct detection of HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA, HCV RNA, HBV DNA in human plasma and serum. 125576/0

Roche Molecular Systems, Inc.

4300 Hacienda Dr. Pleasanton CA 94588-2722

Lic. # 1636

10/20/2016

CUVITRU
Immune Globulin Subcutaneous (Human), 20% Solution
Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. 125596/0 Baxalta US Inc.
One Baxter Way,
Westlake Village, CA, 91362

Lic. # 2020
9/13/2016
CLEVECORD
HPC, Cord Blood
Use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. The risk benefit assessment for an individual patient depends on the patient characteristics, including disease, stage, risk factors, and specific manifestations of the disease, on characteristics of the graft, and on other available treatments or types of hematopoietic progenitor cells. 125594/0 Cleveland Cord Blood Center
25001 Emery Road,
Warrensville Heights, OH, 44128

Lic. # 2026
9/1/2016
Vaxchora
Cholera Vaccine Live Oral
Active immunization against disease caused by Vibrio cholerae serogroup O1. Cholera Vaccine, Live, Oral is approved for use in adults 18 through 64 years of age traveling to cholera-affected areas. 125597/0 Pax Vax Bermuda Ltd.
Clarendon House, 2 church Street,
Hamilton, Hamilton, HM 11, Bermuda

Lic # 2041
6/10/2016

AFSTYLA;
Solchayn

Antihemophilic Factor (Recombinant), Single Chain

Antihemophilic Factor (Recombinant), Single Chain is indicated in children and adults with hemophilia A (congenital Factor VIII deficiency) for: (1) on-demand treatment and control of bleeding episodes, (2) routine prophylaxis to reduce the frequency of bleeding episodes, and (3) perioperative management of bleeding. 125591/0

CSL Behring Recombinant Facility AG
Wankdorfstrasse 10, Bern 22, , 03000, Switzerland

Lic. # 2009
05/25/2016
KOVALTRY
Antihemophilic Factor (Recombinant), Full Length
Antihemophilic Factor (Recombinant) is indicated for use in adults and children with hemophilia A(congenital Factor VIII deficiency) for: (1) on-demand treatment and control of bleeding episodes; (2) perioperative management of bleeding; and (3) routine prophylaxis to reduce the frequency of bleeding episodes. BLA 125574/0 Bayer HealthCare LLC
(b)(4)

Lic. # 0008
3/16/2016
IDELVION
Coagulation Factor IX (Recombinant), Albumin Fusion Protein
Coagulation Factor IX (Recombinant), Albumin Fusion Protein is indicated for (1) control and prevention of bleeding in the perioperative setting, (2) control and prevention of bleeding episodes, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes. BLA 125582/0 CSL Behring Recombinant Facility AG
Wankdorfstrasse 10, Bern 22, 03000, Switzerland

Lic. # 2009
3/4/2016
HPC, Cord Blood For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. 125585/0 Bloodworks
921 Terry Avenue,
Seattle, WA, 98104-1256

Lic #: 2042
1/28/2016