2020 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 |
---|---|---|---|---|
TECARTUS brexucabtagene autoleucel |
TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). | 125703/0 | Kite Pharma, Inc. 2400 Broadway Santa Monica, CA 90404 Lic. #2064 |
07/24/2020 |
Blood Grouping Reagent, Anti-Lea (Murine Monoclonal)(For Further Manufacturing Use)(FFMU) | Indicated for a standard raw material for the manufacture of finished Anti-Lea blood typing diagnostic reagent for in vitro use. This FFMU reacts with the Lea antigen. | 125715/0 | Millipore (UK) Ltd. EMD Millipore Corporation 6600 Sierra College Boulevard Rocklin, CA 95677 Lic. #1761 |
06/18/2020 |
Blood Grouping Reagent, Anti-Leb (Murine Monoclonal)(For Further Manufacturing Use) (FFMU) | Indicated for a standard raw material for the manufacture of finished Anti-Leb blood typing diagnostic reagent for in vitro use. This FFMU reacts with the Leb antigen. | 125716/0 | Millipore (UK) Ltd. EMD Millipore Corporation 6600 Sierra College Blvd Rocklin, CA 95677 Lic. #1761 |
06/18/2020 |
MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine |
Indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. Approved for use in individuals 2 years of age and older. | 125701/0 | Sanofi Pasteur, Inc. Discovery Drive Swiftwater, PA 18370-0187 Lic. #1725 |
04/23/2020 |
SEVENFACT Coagulation Factor VIIa (Recombinant) |
Indicated for treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors. | 125641/0 | Laboratoire Francais du Fractionnement et des Biotechnologies SA (LFB S.A.) LFB USA, Inc. 175 Crossing Boulevard Framingham, MA 01702 Lic. #2061 |
04/01/2020 |
DG® Gel 8 ABO/Rh (2D) Blood Grouping Reagent, Anti-D (Monoclonal Blend) |
For the determination of ABO forward and reverse group, and RhD antigen on the surface of red blood cells of human blood samples. | 125710/0 | Diagnostic Grifols, S.A. Avda de la Generalitat, 152 Sant Cugat del Valles Barcelona 08174 Spain Lic. # 1887 |
03/30/2020 |
AUDENZ Influenza A (H5N1) Monovalent Vaccine, Adjuvanted |
Indicated for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine. | 125692/0 | Seqirus Inc. 50 Hampshire Street 9th Floor Cambridge, MA 02139 Lic. # 2049 |
01/31/2020 |
PALFORZIA Peanut (Arachis hypogaea) Allergen Powder |
Indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. | 125696/0 | Aimmune Therapeutics, Inc. 8000 Marina Boulevard Brisbane, CA 94005-1884 Lic. # 2109 |
01/31/2020 |