Vaccines, Blood & Biologics

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 NameIndication for UseSTNManufacturer/
License No.
Approval Date
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.125314/50Alba Bioscience Limited
Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom

Lic. # 1807
6/22/2018
Cinryze
C1 Esterase Inhibitor (Human)
To expand the indication for routine prophylaxis against angioedema attacks to include pediatric patients ages 6-11 with Hereditary Angioedema.125267/1356ViroPharma Biologics, Inc.
300 Shire Way,
Lexington , MA, 02421

Lic # 1833
6/20/2018
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.125121/80Grifols Diagnostics Solutions, Inc.
4560 Horton Street,
Emeryville, CA, 94608-2916

Lic. # 2032
5/25/2018
KYMRIAH
Tisagenlecleucel
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.125646/76Novartis Pharmaceuticals Corporation
59 Route 10,
East Hanover, NJ, 07936-1080

Lic. # 1244
5/1/2018
Hizentra
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.125350/641CSL Behring AG
Wankdorfstrasse 10, 3000 Berne 22,
Switzerland

Lic # 1766
3/15/2018
FLUARIX ® Quadrivalent
Influenza Virus Vaccine
To extend the age range for use of Fluarix Quadrivalent to include children 6 to 35 months of age.125127/834GlaxoSmithKline Biologicals
Rue de l'Institut 89,
B1330 Rixensart, Belgium

Lic. # 1617
1/11/2018

 

Page Last Updated: 07/23/2018
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