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  1. Development & Approval Process (CBER)

2024 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.

2024 Biological License Application Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License Number
Approval Date
BEQVEZ
elaparvovec-dzkt
Indicated for the treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who: currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and, do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. 125786/0 Pfizer, Inc.
445 Eastern Point Road
Groton, CT 06340

Lic. # 2001
04/25/2024
cobas Malaria
cobas Malaria,
Nucleic Acid Test for
use on the cobas
6800/8800 Systems
Is a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium (P. falciparum, P. malariae, P. vivax, P. ovale and P. knowlesi) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. It is also intended for use in testing whole blood samples to screen organ and tissue donors when samples are obtained while the donor’s heart is still beating. 125808/0 Roche Molecular Systems, Inc.
4300 Hacienda
Drive
Pleasanton, CA
94588-2722

Lic. # 1636
03/19/2024
LENMELDY
atidarsagene autotemcel
Indicated for treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD). 125758/0 Orchard
Therapeutics
(Europe) Limited
Orchard
Therapeutics
North America
101 Seaport
Boulevard, 7th
Floor
Boston, MA 02210

Lic. # 2263
03/18/2024
Elecsys Anti-HCV II
Elecsys Anti-HCV II
An in vitro immunoassay for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma. It is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens. 125803/0 Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250

Lic. # 2305
02/28/2024
Elecsys Anti-HBc II
Elecsys Anti-HBc II
An in vitro immunoassay for the qualitative detection of antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma. It is intended to screen individual human donors, including volunteer donors of whole blood and blood components. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens. 125804/0 Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250

Lic. # 2305
02/27/2024
Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm
Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm
An in vitro immunoassay intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma. It is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens. 125802/0 Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250

Lic. # 2305
02/21/2024
AMTAGVI
Lifileucel
Indicated for treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. 125773/0 Iovance Biotherapeutics, Inc.
825 Industrial Road, Suite 400
San Carlos, CA 94070

Lic. # 2298
02/16/2024
Elecsys Chagas
Elecsys Chagas
An in vitro immunoassay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi, the causative agent of the Chagas disease) in human serum and plasma. It’s intended to screen individual human donors, including volunteer donors of whole blood and blood components. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens. 125799/0 Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250

Lic. # 2305
02/05/2024
Source Plasma Indicated for further manufacturing of injectable products. 125783/0 Life Plasma, Inc.
5438 Perkiomen Avenue
Reading, PA 19606

Lic. # 2311
01/30/2024
Source Plasma Indicated for further manufacturing of injectable products. 125783/0 Life Plasma, Inc.
5438 Perkiomen Avenue
Reading, PA 19606

Lic. # 2311
01/30/2024
CASGEVY
Exagamglogene autotemcel
Indicated the treatment of patients aged 12 years and older with transfusion-dependent ß-thalassemia (TDT). 125785/0 Vertex Pharmaceuticals Inc
50 Northern Avenue
Boston, MA 02210

Lic. # 2279
01/16/2024

 

 
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