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/
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.
Swiftwater, PA 18370-0187
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
|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
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
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