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
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: 06/13/2018
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