A comprehensive table of CBER's 20 new biological approvals and their corresponding approval dates, intended uses, and companies.
As promised in our last blog, 48 New Drug FDA Approvals in 2019, here are the remaining new drugs approved by FDA's Center for Biologics Evaluation and Research (CBER) that were excluded from the previous list!
This listing contains vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, and other products approved in 2019 by CBER.
This list excludes molecular entities approved by FDA’s Center for Drug Evaluation and Research (CDER). To view CDER's list of 48 new drugs in 2019, view our previous post.
We have organized the 20 new biological drugs chronologically in a list below based on their corresponding approval dates.
Enjoy!
| Trade Name | Proper Name | Approval Date | Intended Use | Company |
| 1. Procleix Babesia Assay |
Procleix Babesia Assay |
Jan. 24, 2019 |
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. Screen individual human donors (whole blood, blood components, organ, and tissue). Screen cadaveric (non-heart- beating) donors for B. microti. |
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| 2. ESPEROCT | Antihemophilic Factor (Recombinant), GlycoPEGylated-exei | Feb. 19, 2019 | 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. |  |
| 3. ASCENIV | Immune Globulin Intravenous, Human-slra | April 1, 2019 | Treat primary humoral immunodeficiency for adults and adolescents (12 to 17 years of age) |  |
| 4. Gamma-clone® Blood Grouping Reagent, Anti-k (Monoclonal) | Blood Grouping Reagent, Anti-k (Monoclonal)(IgG) | April 18, 2019 | Detect the k (KEL2) antigen on red blood cells by indirect agglutination tube test |  |
| 5. Gamma-clone® Blood Grouping Reagent, Anti-Cw (Monoclonal) | Blood Grouping Reagent, Anti-Cw (Monoclonal) | April 18, 2019 | Detect the Cw(RH8) antigen on red blood cells by direct agglutination using a tube method. | |
| 6. Gamma-clone® Blood Grouping Reagent, Anti-Fyb (Monoclonal) | Blood Grouping Reagent, Anti-Fyb (Monoclonal) | April 18, 2019 | Detect the Fyb (FY2) antigen on red blood cells by direct agglutination using a tube method. | |
| 7. Blood Grouping Reagent, Anti-k (Monoclonal) (IgG) (For Further Manufacturing Use) | N/A | April 18, 2019 | A standardized raw material for the manufacture of finished Anti-k blood typing reagents/devices for in vitro use |  |
| 8. DENGVAXIA | Dengue Tetravalent Vaccine, Live | May 1, 2019 |
Prevent dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas. |
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| 9. ZOLGENSMA | onasemnogene abeparvovec | May 24, 2019 | Treat 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. |  |
| 10. 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) | June 14, 2019 |
Detect hepatitis B surface antigen (HBsAg) in human serum and plasma specimens on the Alinity s System. Screen individual human donors (whole blood, blood components, organ, and tissue) for the presence of HBsAG. Test serum and plasma specimens to screen live or cadaveric (non-heart-beating) organ donors. |
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| 11. Alinity s HTLV I/II | Human T-Lymphotropic Virus Types I and II (E coli, Recombinant) Antigen and Synthetic Peptides | June 26, 2019 |
Detect 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. Screen individual human donors (whole blood, blood components, organ, and tissue) for the presence of anti‑HTLV I/HTLV II. Test serum and plasma specimens to screen live or cadaveric (non-heart-beating) organ donors. |
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| 12. XEMBIFY | Immune Globulin Subcutaneous (Human) | July 3, 2019 | Treat Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older. |  |
| 13. Alinity s Anti-HCV | Hepatitis C-virus Encoded Antigens (Recombinant c100-3, HCr43) | July 9, 2019 |
Detect antibodies to hepatitis C virus (HCV) in human serum and plasma specimens on the Alinity s System. Screen individual human donors (whole blood, blood components, organ, and tissue) for the presence of anti-HCV. Test serum and plasma specimens to screen live or cadaveric (non-heart-beating) organ donors. |
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| 14. Alinity s HIV Ag/Ab Combo Reagent Kit | Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen, Antibody (p24) and Synthetic Peptide | July 23, 2019 |
Detect human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma specimens on the Alinity s System. Screen individual human donors (whole blood, blood components, organ, and tissue) for the presence of antiHIV-1/HIV-2 and HIV-1 p24 antigen. Test serum and plasma specimens to screen live or cadaveric (non-heart-beating) organ donors. |
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| 15. Alinity s Anti-HBc | Hepatitis B Virus Core Antigen (E.coli, Recombinant) | Aug. 2, 2019 |
Detect antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma specimens on the Alinity s System. Screen individual human donors (whole blood, blood components, organ, and tissue) for the presence of anti-HBc. Test serum and plasma specimens to screen live or cadaveric (non-heart-beating) organ donors. |
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| 16. N/A | Blood Grouping Reagent, Anti A (Muring Monoclonal) (FFMU) | Aug. 12, 2019 | Further manufacture Blood Grouping Reagents. |  |
| 17. Alinity s Chagas | Trypanosoma cruzi (E. coli, Recombinant) Antigen | Aug. 15, 2019 |
Detect antibodies to T. cruzi (the causative agent of Chagas disease) in human serum and plasma specimens on the Alinity s System. Screen individual human donors (whole blood, blood components, organ, and tissue) for the presence of antibodies to T. cruzi. Test serum and plasma specimens to screen live or cadaveric (non-heart-beating) organ donors. |
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| 18. Geenius HIV 1/2 Supplementary Assay | Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptides) | Aug. 26, 2019 |
Single-use immunochromatographic assay to confirm and differentiate individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in serum or plasma samples (EDTA, lithium heparin, sodium citrate, and CPD) from blood donors. The results of the Geenius HIV 1/2 Supplemental Assay are read and interpreted only with the Geenius Reader with dedicated software. |
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| 19. cobas® Babesia | cobas Babesia test for use on the cobas 6800/8800 Systems | Aug. 29, 2019 |
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. |
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| 20. JYNNEOS | Modified Vaccinia Ankara - Bavarian Nordic (MVA-BN) | Sept. 24, 2019 | Prevent smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. |  |
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Sources:
Center for Biologics Evaluation and Research, FDA. “2019 Biological License Application Approvals.” U.S. Food and Drug Administration, FDA, 2019, www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2019-biological-license-application-approvals.