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.
| 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 |