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  1. Development & Approval Process (CBER)

2021 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.

2021 Biological License Application Supplement Noteworthy Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License No.
Approval Date
Zoster Vaccine Recombinant, Adjuvanted
To expand the indication to include the prevention of herpes zoster (HZ) (shingles) in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy. 125614/398 GlaxoSmithKline Biologicals
14200 Shady Grove Road
Rockville, MD 20850-7464

Lic. # 1617
Immune Globulin Intravenous (Human)
To include the additional indication for treatment of dermatomyositis in adults. 125062/674 OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
117 West Century Rd.
Paramus, NJ 07652

Lic. # 1646
Antihemophilic Factor (Recombinant) PEGylated
This submission fulfils the post marketing requirement PMR# 3 identified in November 13, 2015, approval letter for BLA STN 125566/0.

This submission fulfils the post marketing commitments (PMCs) #6 identified in the November 13, 2015, approval letter for BLA STN 125566/0.
125566/607 Baxalta US, Inc.
650 East Kendall Street
Cambridge, MA 02142

Lic. # 2020
Fibrinogen Concentrate (Human)
Fulfills the post marketing requirements for PMR #1: Post marketing Study Requirement Final Study Report BI3023_4003 made under 21 CFR 601.41 125317/231 CSL Behring GmbH
CLS Behring, LLC
1020 First Avenue
P.O. Box 6150
King of Prussia, PA 19406

Lic. # 1765
Rabies Immune Globulin (Human)
1. Submit the Final Study Report for the Required Pediatric Assessment as agreed to in Postmarketing Requirement #1 in Kamada's August 23, 2017 BLA approval letter (STN BL 125613/0) and,
2. Update the prescribing information.
125613/76 Kamada Ltd.
1555 King Street
Suite 300
Alexandria, VA 22314

Lic. # 1826
Immune Globulin Subcutaneous (Human), 20% Liquid
To update the Dosage and Administration, Adverse Reactions and Clinical Studies sections of the US Prescribing Information based on the results from Study IgPro20_3004, open-label extension study that investigated the long-term safety and efficacy of the product in the maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). 125350/969 CSL Behring AG
CSL Behring LLC
1020 First Avenue
P.O.Box 61501
King of Prussia, PA 19406-0901

Lic. # 1766
axicabtagene ciloleucel
To update the existing United States Prescribing Information (USPI) for YESCARTA with safety results from the Phase 2 Safety Management Cohort 4 from Study ZUMA-1, which assessed the effect of earlier intervention with corticosteroids and/or tocilizumab on the incidence and severity of CRS and neurologic events. 125643/231 Kite Pharma Inc.
2400 Broadway
Santa Monica, CA 90404
Lic. # 2064
Short Ragweed Pollen Allergen Extract
For use in children and adolescents 5 to 17 years of age. Short Ragweed Pollen Allergen Extract is indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. RAGWITEK is approved for use in persons 5 through 65 years of age. 125478/293 ALK-Abello A/S
135 Route 202/206 Suite 3
Bedminster, NJ 20879

Lic. # 1292
axicabtagene ciloleucel
To include a new indication for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. 125643/248 Kite Pharma, Inc.
2400 Broadway
Santa Monica, CA 90404

Lic. # 2064
Flucelvax Quadrivalent
Influenza Vaccine
To extend the use of FLUCELVAX QUADRIVALENT manufactured at the Holly Springs, NC and -------(b)(4)------ facilities to persons 2 years of age and older. 125408/329 Seqirus Inc.
50 Hampshire Street, 9th Floor
Cambridge, MA 02139

Lic. # 2049
Immune Globulin Intravenous (Human)-ifas 10%
Include the following: 1. a new indication for the treatment of adults 18 years of age and older with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment, and
2. to remove the distinction between new and experienced patients in section 2.1 in the prescribing information label.
125587/70 Octapharma Pharmazeutika Produktionsges.m.b.H
Octapharma USA.
117 West Century Rd.
Paramus, NJ 07652

Lic. # 1646
Antihemophilic Factor (Recombinant), Full Length
To provide the Clinical Study Report (CSR) for Postmarketing Commitment #1 noted in the approval letter for STN BL 125574/0 and to update Section 6 of the Prescribing Information to include information related to inhibitor development in previously untreated patients with hemophilia A. 125574/400 Bayer HealthCare LLC
100 Bayer Boulevard
P.O. Box 915
Whippany, NJ 07981-0915

Lic. # 0008
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