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.
| Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|---|
| 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 |