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  1. Development & Approval Process (CBER)

2018 Biological License Application Supplement Noteworthy Approvals

This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed by date of approval, with the most recent action at the top.

2018 Biological License Application Supplement Noteworthy Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License No.
Approval Date
Antihemophilic Factor (Recombinant)
To update the data from the NN7008-3568 and NN7008-3809 trials in the prescribing information label and to change the indication from “Control and prevention of bleeding episodes” to “on-demand treatment and control of bleeding episodes,” to change the frequency of dosing of adults and adolescents, to update the “Neutralizing Antibodies” section, to update the “ADVERSE REACTIONS” section, to update the “Immunogenicity” section, to update the “Pediatric Use” section, and to update the “CLINICAL STUDIES” section. 125466/243 Novo Nordisk Inc.
P.O.Box 846,
800 Scudders Mill Road,
Plainsboro, NJ 08536

Lic. # 1261
Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract
Treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product (for use in persons 10 through 65 years of age) 125471/230 Stallergenes, SAS
55 Cambridge Parkway, Suite 400
Cambridge, MA 02142

Lic. # 1893
Gardasil 9
Human Papillomavirus 9-valent Vaccine, Recombinant
To extend the age range for the use of the vaccine to include women and men from 27 to 45 years of age. 125508/493 Merck Sharp & Dohme Corp.
1 Merck Drive,
Whitehouse Station, NJ 08889-0100
United States

Lic. #0002
Japanese Encephalitis Vaccine, Inactivated, Adsorbed
To: i) include an alternate primary immunization series of tw0 0.5 mL doses of IXIARO administered at 7 days apart for indivuduals 18 through 65 years of age, and ii) update the IXIARO package insert to include data to support the concomitant use of IXIARO primary immunization series, two 0.5 mL doses administered 28 days apart, with U.S.-licensed rabies vaccine (RabAvert®) administered for pre-exposure prophylaxis. 125280/251 Valneva Austria GmbH
Campus Vienna Biocenter 3,
Vienna, A-1030

Lic. # 1909
Afluria Quadrivalent, AFLURIA
Influenza Vaccine
To fulfill PREA PMR #2 from STN 125254/565 and extend the indication of Afluria and Afluria Quadrivalent to persons 6 through 59 months of age. 125254/692 Seqirus Pty Ltd.
45 Poplar Road,
Parkville, Victoria, Australian Capital Territory 3052

Lic. # 2044
Coagulation Factor X (Human)
This is a PAS Efficacy Supplement submitted by BPL to BL 125506 for Coagulation Factor X (Human) [COAGADEX] for the following proposed indications for use with no age restrictions:

(1) Routine prophylaxis to prevent or reduce the frequency of bleeding episodes; (2) on-demand treatment and control of bleeding episodes; and (3) perioperative management of bleeding in patients with mild hereditary Factor X deficiency
125506/46 Bio Products Laboratory
Dagger Lane, Elstree,
Hertfordshire, WD6 3BX
United Kingdom

Lic. # 1811
Blood Grouping Reagent, Anti-D (Monoclonal Blend) To include the manufacture of Albaclone®Anti-D fusion at your facility located Edinburgh, Scotland, United Kingdom. Albaclone® Anti-D fusion is for the in vitro detection and identification of human RhoD blood group status in patient and donor samples by direct agglutination and indirect antiglobulin test using tube techniques. 125314/50 Alba Bioscience Limited
Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom

Lic. # 1807
C1 Esterase Inhibitor (Human)
To expand the indication for routine prophylaxis against angioedema attacks to include pediatric patients ages 6-11 with Hereditary Angioedema. 125267/1356 ViroPharma Biologics, Inc.
300 Shire Way,
Lexington , MA, 02421

Lic # 1833
Procleix WNV Assay
West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic)
Qualitative in vitro nucleic acid amplification test to detect WNV RNA in human plasma. 125121/80 Grifols Diagnostics Solutions, Inc.
4560 Horton Street,
Emeryville, CA, 94608-2916

Lic. # 2032
To add a new indication for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. 125646/76 Novartis Pharmaceuticals Corporation
59 Route 10,
East Hanover, NJ, 07936-1080

Lic. # 1244
Immune Globulin Subcutaneous (Human), 20% Liquid
To include the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. 125350/641 CSL Behring AG
Wankdorfstrasse 10, 3000 Berne 22,

Lic # 1766
FLUARIX Quadrivalent
Influenza Virus Vaccine
To extend the age range for use of Fluarix Quadrivalent to include children 6 to 35 months of age. 125127/834 GlaxoSmithKline Biologicals
Rue de l'Institut 89,
B1330 Rixensart, Belgium

Lic. # 1617


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