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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
YESCARTA
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
03/05/2021
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
03/03/2021
PANZYGA®
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
02/11/2021
KOVALTRY
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
01/08/2021
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