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  1. Development & Approval Process (CBER)

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.

2020 Biological License Application Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License Number
Approval Date
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
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.)
175 Crossing Boulevard
Framingham, MA 01702

Lic. #2061
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

Lic. # 1887
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
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
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