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 |
|---|---|---|---|---|
| TRUMENBA Meningococcal Group B Vaccine |
To include data from the confirmatory clinical study conducted to verify and describe the clinical benefit of the two-dose schedule (a dose administered at 0 and 6 months) of Trumenba in individuals 10 through 25 years of age. | 125549/737 | Wyeth Pharmaceuticals, LLC 401 N. Middletown Road Pearl River, NY 10965 Lic. # 0003 |
11/19/2021 |
| CUTAQUIG Immune Globulin Subcutaneous (Human)-hipp |
Update the prescribing information and expand the use of Cutaquig to pediatric patients ages two to < 17 years of age for the treatment of primary humoral immunodeficiency. | 125668/158 | OCTAPHARMA Pharmazeutika Produktionsges.m.b.H. 17 West Century Road Paramus, NJ 07652 Lic. # 1646 |
10/22/2021 |
| Flucelvax Quadrivalent Influenza Vaccine |
To extend the use of FLUCELVAX QUADRIVALENT manufactured at the Holly Springs, NC; --------- (b)(4) ----------- facilities, to persons 6 months of age and older. | 125408/351 | Seqirus, Inc. 475 Green Oaks Parkway Holly Springs, NC 27540 Lic. # 2049 |
10/14/2021 |
| TECARTUS brexucabtagene autoleucel |
To add a new indication for adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL). | 125703/91 | Kite Pharma, Inc. 2400 Broadway Santa Monica, CA 90404 Lic. # 2064 |
10/01/2021 |
| SHINGRIX 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 VR1500 Rockville, MD 20850-7464 Lic. # 1617 |
07/23/2021 |
| OCTAGAM 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 |
07/15/2021 |
| ADYNOVATE 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 |
06/14/2021 |
| RiaSTAP 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 |
06/04/2021 |
| KEDRAB 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 |
05/17/2021 |
| Hizentra 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 |
04/23/2021 |
| YESCARTA 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 |
04/22/2021 |
| RAGWITEK 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 |
04/16/2021 |
| 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 |