20 New FDA Biological Approvals in 2019

Posted by Sierra Labs on Jan 14, 2020 1:10:01 PM

A comprehensive table of CBER's 20 new biological approvals and their corresponding approval dates, intended uses, and companies.

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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!

 

20 New FDA Biological Drug Approvals in 2019

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. novo-logo-dhpx.image.136.0
3. ASCENIV Immune Globulin Intravenous, Human-slra April 1, 2019 Treat primary humoral immunodeficiency for adults and adolescents (12 to 17 years of age) header-logo
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 WelcomeToImmucor
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. WelcomeToImmucor
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. WelcomeToImmucor
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 logo-rb-ms
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.

sanofi-aventis-logo-vector
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. 140px-AveXis.svg
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. logo
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.

abbott
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.

abbott
16. N/A Blood Grouping Reagent, Anti A (Muring Monoclonal) (FFMU) Aug. 12, 2019 Further manufacture Blood Grouping Reagents. Logo_Diagast
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. 1200px-Bavarian_Nordic_logo.svg

 

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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.

Topics: FDA, Compliance, CDER, New Drugs, Center for Biologics Evaluation and Research, Drug Approval, FDA Approval

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