2019 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.
| Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|---|
| ERVEBO Ebola Zaire Vaccine, Live |
ERVEBO® is a vaccine indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. | 125690/0 | Merck Sharp & Dohme Corp. 351 N. Sumneytown Pike, P.O. Box 1000, UG2D-068, North Wales, PA 19454 Lic. # 0002 |
12/19/2019 |
| JYNNEOS Modified Vaccinia Ankara - Bavarian Nordic (MVA-BN) |
For prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. | 125678/0 | Bavarian Nordic A/S 3025 Carrington Mill Boulevard Morrisville, NC 27560 Lic. # 2096 |
09/24/2019 |
| cobas® Babesia cobas Babesia test for use on the cobas 6800/8800 Systems |
The cobas® Babesia test for use on the cobas® 6800/8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Babesia DNA and RNA in whole blood. | 125699/0 | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 Lic. # 1636 |
08/29/2019 |
| Geenius HIV 1/2 Supplementary Assay Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptides) |
The Geenius™ HIV 1/2 Supplemental Assay is a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in serum or plasma samples (EDTA, heparin, and sodium citrate). The results of the Geenius HIV ½ Supplemental Assay are read and interpreted only by the Geenius Reader with dedicated software. | 125670/0 | Bio-Rad Laboratories 6565 185th Avenue NE Redmond, WA 98052-5039 Lic. # 1109 |
08/26/2019 |
| Alinity s Chagas Trypanosoma cruzi (E. coli, Recombinant) Antigen |
The Alinity s Chagas assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to Trypanosoma cruzi (the causative agent of Chagas disease) in human serum and plasma specimens on the Alinity s System. The Alinity s Chagas assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of antibodies to Trypanosoma 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, and in testing serum specimens to screen cadaveric (non-heart-beating) donors. It’s not intended for use on cord blood specimens. |
125689/0 | Abbott GMbH & Co. KG Abbott Laboratories Dept. 09TR, Bldg. AP8A 100 Abbott Park Road Abbott Park, IL 60064-6092 Lic. # 2095 |
08/15/2019 |
| Blood Grouping Reagent, Anti-A (Murine Monoclonal) (For Further Manufacturing Use) | The Blood Grouping Reagent, Anti-A (Murine Monoclonal) (For Further Manufacturing Use) is to be utilized by Diagnostic Grifols, S.A. in the manufacture of the final product, Blood Grouping Reagent, Anti-A, under a shared manufacturing agreement. | 125680/0 | Diagast NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426 Lic. # 1744 |
08/12/2019 |
| Blood Grouping Reagent, Anti-A (Murine Monoclonal) (For Further Manufacturing Use | The Blood Grouping Reagent, Anti-A (Murine Monoclonal)(For Further Manufacturing Use) is to be utilized by Diagnostic Grifols, S.A. in the manufacture of the final product, Blood Grouping Reagent, Anti-A (Murine Monoclonal), under a shared manufacturing agreement. | 125669/0 | Diagast Parc Eurasante, Loos Cedex, 59374 Lic # 1744 |
8/12/2019 |
| Alinity s Anti-HBc assay Hepatitis B Virus Core Antigen (E.coli, Recombinant) |
The Alinity s Anti-HBc assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HBc. 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, and in testing serum specimens to screen cadaveric (non-heart-beating) donors. | 125681/0 | Abbott GMbH & Co. KG Abbott Laboratories Dept. 09TR, Bldg. AP8A 100 Abbott Park Road Abbott Park, IL 60064-6092 Lic. # 2095 |
08/02/2019 |
| Alinity s HIV Ag/Ab Combo assay Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen, Antibody (p24) and Synthetic Peptide |
The Alinity s HIV Ag/Ab Combo assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HIV-1/HIV-2 and HIV-1 p24 antigen. 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, and in testing serum specimens to screen cadaveric (nonheart-beating) donors. It is not intended for use on cord blood specimens. | 125679/0 | Abbott GMbH & Co. KG Abbott Laboratories Dept. 09TR, Bldg. AP8A 100 Abbott Park Road Abbott Park, IL 60064-6092 Lic. # 2095 |
07/23/2019 |
| Alinity s Anti-HCV assay Hepatitis C-virus Encoded Antigens (Recombinant c100-3, HCr43) |
The Alinity s Anti-HCV assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma specimens on the Alinity s System. | 125677/0 | Abbott GMbH & Co. KG Abbott Laboratories Dept. 09TR, Bldg. AP8A 100 Abbott Park Road Abbott Park, IL 60064-6092 Lic # 2095 |
7/9/2019 |
| XEMBIFY Immune Globulin Subcutaneous (Human) |
Immune globulin subcutaneous, human-klhw, 20% is indicated for the treatment of Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. | 125683/0 | Grifols Therapeutics LLC 8368 US 70 Business Highway West Clayton, NC 27520 Lic. # 1871 |
07/03/2019 |
| Alinity s HTLV I/II assay Human T-Lymphotropic Virus Types I and II (E coli, Recombinant) Antigen and Synthetic Peptides |
The Alinity s HTLV I/II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to human T-lymphotropic virus Type I and/or human T-lymphotropic virus Type II (anti-HTLV I/HTLV II) in human serum and plasma specimens on the Alinity s System. The Alinity s HTLV I/II assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HTLV I/HTLV II. 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, and in testing serum specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens. | 125675/0 | Abbott GMbH & Co. KG Abbott Laboratories, Dept 09TR, Bldg. AP8A-1, 100 Abbott Park Road, Abbott Park, IL 60064-6092 Lic. # 2095 |
06/26/2019 |
| Abbott Alinity s HBsAg and Abbott Alinity s HBsAg Confirmatory Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgG and IgM) and Antibody to Hepatitis B Surface Antigen (Sheep) |
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgG and IgM) [Abbott Alinity s HBsAg] is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma specimens on the Alinity s System. The Abbott Alinity s HBsAg assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of HBsAg. 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, and in testing serum specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens. Antibody to Hepatitis B Surface Antigen (Sheep) [Alinity s HBsAg Confirmatory] is used to confirm the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma by means of specific antibody neutralization on the Alinity s System. The assay is intended to be used for confirmation of samples found to be repeatedly reactive by the Alinity s HBsAg assay. | 125674/0 | Abbott Ireland Diagnostics Division Abbott Laboratories, Dept 09TR, Bldg. AP8A-1, 100 Abbott Park Road, Abbott Park, IL 60064-6092 Lic. # 2094 |
06/14/2019 |
| ZOLGENSMA onasemnogene abeparvovec |
Indicated for treatment of pediatric patients less than two years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. | 125694/0 | AveXis, Inc. 2275 Half Day Rd., Suite 200, Bannockburn, IL 60015 Lic. # 2104 |
05/24/2019 |
| DENGVAXIA Dengue Tetravalent Vaccine, Live |
Dengue Tetravalent Vaccine, Live is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. Dengue Tetravalent Vaccine, Live is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas. | 125682/0 | Sanofi Pasteur Inc. Discovery Drive, Swiftwater, PA 18370-0187 Lic. # 1725 |
05/01/2019 |
| Blood Grouping Reagent, anti-k (Monoclonal)(IgG) (For Further Manufacturing use) | To be used by -----(b)(4)--- for the manufacture of ---------(b)(4)-----------------------------------, under a shared manufacturing arrangement. | 125684/0 | Millipore (UK) Ltd. EMD Millipore Corporation, 6600 Sierra College Boulevard, Rocklin, CA 95677 Lic. # 1761 |
04/18/2019 |
| Gamma-clone® Blood Grouping Reagent, Anti-Fyb (Monoclonal) Blood Grouping Reagent, Anti-Fyb (Monoclonal) |
Indicated for the detection of the Fyb (FY2) antigen on red blood cells by direct agglutination using a tube method. | 125686/0 | Immucor, Inc. 3130 Gateway Drive, Norcross, GA 30071 Lic. # 0886 |
04/18/2019 |
| Gamma-clone® Blood Grouping Reagent, Anti-Cw (Monoclonal) Blood Grouping Reagent, Anti-Cw (Monoclonal) |
Indicated for the detection of the Cw(RH8) antigen on red blood cells by direct agglutination using a tube method. | 125687/0 | Immucor, Inc. 3130 Gateway Drive, Norcross, GA 30071 Lic. # 0886 |
04/18/2019 |
| Gamma-clone® Blood Grouping Reagent, Anti-k (Monoclonal) (IgG) Blood Grouping Reagent, Anti-k (Monoclonal)(IgG) |
Indicated for the detection of the k (KEL2) antigen on red blood cells by indirect antiglobulin test by tube method. | 125688/0 | Immucor, Inc. 3130 Gateway Drive, Norcross, GA 30071 Lic. # 0886 |
04/18/2019 |
| ASCENIV Immune Globulin Intravenous, Human-slra |
Indicated for the treatment of primary humoral immunodeficiency in adults and adolescents (12 to 17 years of age). | 125590/0 | ADMA Biologics, Inc. 5800 Park of Commerce Boulevard, N.W. Boca Raton, FL 33487 Lic. # 2019 |
04/01/2019 |
| ESPEROCT Antihemophilic Factor (Recombinant), GlycoPEGylated-exei |
For use in adults and children with hemophilia A 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. | 125671/0 | Novo Nordisk, Inc. P. O. Box 846, 800 Scudders Mill Road, Plainsboro, NJ 08536 Lic. # 1261 |
02/19/2019 |
| Procleix Babesia Assay Procleix Babesia Assay |
A qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens. It is intended for use in screening individual human donors, including volunteer donors of whole blood and blood components, and in screening living donors of organ and tissue. It is also intended for use in screening cadaveric (non-heart-beating) donors for B. microti. | 125673/0 | Grifols Diagnostic Solutions Inc. 10210 Genetic Center Drive, San Diego, CA 92121-4362 Lic. # 2032 |
01/24/2019 |