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  1. Vaccines, Blood & Biologics

2018 Biological License Application Approvals

2018 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 in reverse chronological order.

2018 Biological License Application Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License Number
Approval Date
VAXELIS
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine
VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. VAXELIS is approved for use as a 3 dose series in children from 6 weeks through 4 years of age (prior to the 5th birthday). 125563/0 MCM Vaccine Company
Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370-0187
United States

Lic. # 2007
12/21/2018
Haemophilus b Conjugate (Meningococcal Protein Conjugate) Bulk (For Further Manufacturing Use) To include use of the Haemophilus b Conjugate (Meningococcal Protein Conjugate) Bulk Intermediate in the combination vaccine Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine 125580 Merck Sharp & Dohme Corp.
1 Merck Drive,
P.O. Box 100,
Whitehouse Station, NJ 08889-0100
United States

Lic. # 0002
12/21/2018
Hepatitis B Vaccine (Recombinant) Bulk (For Further Manufacturing Use) To include an alternate manufacturing process to facilitate the use of the Hepatitis B surface antigen in the combination vaccine Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine. 125581 Merck Sharp & Dohme Corp.
1 Merck Drive,
P.O. Box 100,
Whitehouse Station, NJ 08889-0100
United States

Lic. # 0002
12/21/2018
CUTAQUIG
Immune Globulin Subcutaneous (Human)-hipp
Indicated for treatment of primary humoral immunodeficiency (PI) in adults 125668/0 Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Strasse 235, A-1100
Vienna, Austria

Lic. # 1646
12/12/2018
JIVI
Antihemophilic Factor (Recombinant), PEGylated
Indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for: on demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes 125661/0 Bayer HealthCare LLC
--------(b)(4)--------------------------- ---------

Lic. # 8
8/29/2018
PANZYGA
Immune Globulin Intravenous (Human)-ifas
Indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older and chronic immune thrombocytopenic purpura (ITP) in adults 125587/0 Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Strasse 235,
Vienna, Austria

Lic. # 1646
8/2/2018
Procleix Zika Virus Assay The Procleix Zika Virus Assay is a qualitative in vitro nucleic acid test for the detection of Zika Virus (ZIKV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components for transfusion. It is also intended for use in testing plasma or serum specimens to screen other living (heart-beating) donors of organs and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), and in testing blood specimens to screen cadaveric (non- heart-beating) donors. It is not intended for use on cord blood specimens. 125667/0 Grifols Diagnostic Solutions Inc.
4560 Horton Street,
Emeryville, CA 94608-2916

Lic. # 2032
7/5/2018
Hematopoietic Progenitor Cells, Cord (HPC-C) It’s indicated 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. 125657/0 MD Anderson Cord Blood Bank
1841 Old Spanish Trail,
Houston, TX, 77054

Lic. # 2072
6/21/2018
Blood Grouping Reagent, Anti-k (Murine Monoclonal)(For Further Manufacturing Use) It’s indicated for the manufacture of Blood Grouping Reagent, Anti-k (Murine Monoclonal) by Bio-Rad Medical Diagnostics GmbH., located in Dreieich, Germany, U.S. licencse No. 1845, under a shared manufacturing arrangement. 125662/0 Alba Bioscience Limited
Ellen's Glen Road, Edinburgh EH17 7QT, TX United Kingdom

Lic. # 1807
6/21/2018
ALBUMINEX
Human Albumin Solution (HAS) 5% and 25%
Albumin, human-kjda 5% and albumin, human-kjda 25% are indicated for hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardiopulmonary bypass. 125644/0 Bio Products Laboratory
Dagger Lane, Hertfordshire, WD6 3BX United Kingdom

Lic. # 1811
6/19/2018
UltraQual Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV The UltraQual® Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV --(b)(4)---- Primers and Probes) is to screen pooled source plasma in conjunction with NGI’s pooling and testing algorithm. The assay simultaneously detects HCV RNA, HIV-1 RNA (including Group M and Group O), HIV-2 RNA, and HBV DNA. This assay discriminates between HCV, HIV-1, HIV-2 and HBV positive samples but will not discriminate between HIV-1 Group M and Group O positive samples. This is an “in-house” test performed only by NGI. 125658/0 National Genetics Institute
------------------------------
----(b)(4)--------------------
--------------------

Lic. # 1582
5/30/2018
Plasma Cryoprecipitate (For Further Manufacturing Use) Cryoprecipitate will be used as starting material for the manufacture of -----(b)(4)---- (Human), trade name (b)(4), manufactured by ----- --------(b)(4)-----------------. 125660/0 Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Strasse 235,
Vienna, Austria

Lic. # 1646
5/3/2018
Procleix Ultrio Elite Assay The Procleix® Ultrio Elite Assay is a qualitative in vitro nucleic acid amplification test to screen for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV) RNA, and/or hepatitis B virus (HBV) DNA and to detect human immunodeficiency virus type 2 (HIV-2) RNA, in plasma and serum specimens from human donors, including donors of whole blood, blood components, and source plasma, and from other living donors. 125652/0 Grifols Diagnostics Solutions, Inc.
4560 Horton Street,
Emeryville, CA, 94608-2916

Lic. # 2032
5/3/2018
ANDEXXA
Coagulation Factor Xa (Recombinant), Inactivated
Indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-theratening or uncontrolled bleeding. 125586/0 Portola Pharamceuticals
270 East Grand Avenue,
South San Francisco, CA, 94080

Lic. # 2017
5/3/2018
Babesia microti Arrayed Fluorescence Immunoassay The Imugen Babesia microti Arrayed Fluorescence Immunoassay (AFIA) is intended for qualitative detection of antibodies to Babesia microti in human plasma (EDTA anti-coagulated) samples. 125589/0 Oxford Immunotec Ltd.
94C Innovation Drive, Milton Park
Abingdon, Oxford
OX14 4RZ UK

Lic # 2021
3/6/2018
Babesia microti Nucleic Acid Test The Imugen Babesia microti NAT is a nucleic acid screening assay for the detection of Babesia microti DNA in human whole blood samples (with EDTA as anti-coagulant) 125588/0 Oxford Immunotec Ltd.
94C Innovation Drive, Milton Park
Abingdon, Oxford
OX14 4RZ UK

Lic # 2021
3/6/2018
Blood Grouping Reagent, Anti-C (Human/Murine Monoclonal)
Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal)
Blood Grouping Reagent, Anti-Cw (Human/Murine Monoclonal)

 
The blood Grouping Reagents are intended for the in vitro detection and identification of the human C, e, Cw blood group antigens by direct agglutination. 125599/0
125600/0
125601/0
Alba Bioscience Limited
Ellen's Glen Road,
Edinburgh EH17 7QT, United Kingdom

Lic # 1807
2/15/2018
Blood Grouping Reagent, Anti-A (Murine Monoclonal)
Blood Grouping Reagent, Anti-B (Murine Monoclonal)
Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal)
Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal Blend)
Blood Grouping Reagent, Anti-C (Human/Murine Monoclonal)
Blood Grouping Reagent, Anti-E (Human/Murine Monoclonal)
Blood Grouping Reagent, Anti-c (Human/Murine Monoclonal)
Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal)
Blood Grouping Reagent, Anti-K (Human/Murine Monoclonal)
Blood Grouping Reagent, Anti-A (Murine Monoclonal) - This reagent is designed to determine the presence of ABO system blood group antigen A on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-B (Murine Monoclonal) - This reagent is designed to determine the presence of ABO system blood group antigen B on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal); Blood Grouping Reagent, Anti-D(Human/Murine Monoclonal Blend) - These reagents are designed to determine the presence of the blood Rhesus antigen D (RH1) on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-C (Human/Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen C (Rh2) on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-E (Human/Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen E (Rh3) on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-c (Human/Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen c (Rh4) on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-e (Human/Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen e (Rh5) on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-K (Human/Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen K on the surface of human red blood cells by manual method.
125615/0
125619/0
125620/0
125621/0
125622/0
125623/0
125624/0
125625/0
125626/0
Diagast
Parc Eurasante
251, av.Eugene Avinee - BP9
Loos Cedex, France 59374

Lic # 1744
2/2/2018
Blood Grouping Reagents Anti Human Globulin Anti-IgG, C3d

Anti_Human Globulin Anti_IgG is intended for use in the direct antiglobulin test to detect in vivo coating on human red blood cells with IgG and for the indirect antiglobulin test for antibody screening and identification, and crossmatch and for erythrocyte phenotyping with blood phenotyping reagents requiring an indirect antiglobulin test method.

Anti-Human Globulin Anti-C3d is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with C3d components. Anti-Human Globulin Anti-C3d only recognizes the complement fragment and, consequently, cannot react with component C4.

Anti-Human Globulin Anti-IgG,-C3d is intended for use in the direct antiglobulin test to detect the in vivo coating on human red blood cells with IgG and/or C3d components. In addition to recognizing IgG antibodies and the complement fragment C3d, Anti Human Globulin Anti-IgG, C3d is able to recognize IgM antibodies on the surface of red blood cells since IgM antibodies always fix complement in vivo (and in vitro if the reaction occurs in the presence of complement: i.e., when using a fresh sample).

125616/0 Diagast
Parc Eurasante
251, av.Eugene Avinee - BP9
Loos Cedex, France 59374

Lic # 1744
2/2/2018
Blood Grouping Reagent, Anti-A,B (Murine Monoclonal)
Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal)(IgG)
Blood Grouping Reagent, Anti-Fyb (Human/Murine Monoclonal)
Blood Grouping Reagent, Anti-Jka (Human/Murine Monoclonal)
Blood Grouping Reagent, Anti-Jkb Human(Murine Monoclonal)
Blood Grouping Reagent, Anti-M (Murine Monoclonal)(IgG)
Blood Grouping Reagent, Anti-S (Human/Murine Monoclonal)(IgG)
Blood Grouping Reagent, Anti-Lea (Murine Monoclonal)
Blood Grouping Reagent, Anti-Leb (Murine Monoclonal)

Blood Grouping Reagent, Anti-A,B (Murine Monoclonal) - This reagent is designed to determine the presence of ABO system blood group antigen A and B on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-D (Human/Murine Monoclonal) IgG - This reagent is designed to determine the presence of the blood Rhesus antigen D (RH1) on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-Fyb (Human/Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen Fyb (FY2) on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-Jka (Human/Murine Monoclonal Blend) - This reagent is designed to determine the presence of the blood group antigen Jka (JK1) on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-Jkb (Human/Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen Jkb (JK2) on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-M (Murine Monoclonal) (IgG) - This reagent is designed to determine the presence of the blood group antigen M (MNS1) on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-S (Human/Murine Monoclonal) (IgG) - This reagent is designed to determine the presence of the blood group antigen S (MNS3) on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-Lea (Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen Lea (LE1) on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti- Leb (Murine Monoclonal) - This reagent is designed to determine the presence of the blood group antigen Leb (LE) on the surface of human red blood cells by manual method.

125617/0
125629/0
125630/0
125631/0
125632/0
125633/0
125634/0
125635/0
125636/0
Diagast
Parc Eurasante
251, av.Eugene Avinee - BP9
Loos Cedex, France 59374

Lic # 1744
2/2/2018
Blood Grouping Reagent, Anti-s (Human/Murine Monoclonal)(IgG)
Blood Grouping Reagent, Anti-P1 (Murine Monoclonal)
Blood Grouping Reagent, Anti-Fya (Human/Murine Monoclonal)(IgG)

Blood Grouping Reagent, Anti-s (Human/Murine Monoclonal), IgG - This reagent is designed to determine the presence of blood group antigen s on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-P1 (Murine Monoclonal) - This reagent is designed to determine the presence of blood group antigen P1 on the surface of human red blood cells by manual method.

Blood Grouping Reagent, Anti-Fya (Human/Murine Monoclonal), IgG - These reagents are designed to determine the presence of the blood group antigen Fya on the surface of human red blood cells by manual method.

125618/0
125627/0
125628/0
Diagast
Parc Eurasante
251, av.Eugene Avinee - BP9
Loos Cedex, France 59374

Lic # 1744
2/2/2018