2022 Biological License Application Approvals
This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval in reverse chronological order.
| Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|---|
| Platelets | To manufacture Apheresis Platelets, Platelet Additive Solution (PAS-C) Added, Leukocytes Reduced, Psoralen–Treated, collected on the --------(b)(4)----- ------ (b)(4)-------- and pathogen reduced using the ---(b)(4)--- -----(b)(4)---------------- ------ for Platelets. | 125766/0 | Secure Transfusion Solutions, Inc. 611 Gateway Boulevard, Suite 120 South San Francisco, CA 94080 Lic. # 2285 |
12/23/2022 |
| ADSTILADRIN nadofaragene firadenovec |
Indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. | 125700/0 | Ferring Pharmaceuticals A/S ICON Clinical Research LLC 4130 Parklake Avenue, Suite 400 Raleigh, NC 27612 Lic. # 2222 |
12/16/2022 |
| REBYOTA fecal microbiota, live-jslm |
Indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. | 125739/0 | Ferring Pharmaceuticals Inc. 2660 Patton Road Roseville, MN 55113 Lic. # 2112 |
11/30/2022 |
| HEMGENIX etranacogene dezaparvovec-drlb |
Indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. | 125772/0 | CSL Behring LLC 1020 First Avenue P.O. Box 61501 King of Prussia, PA 19406-0901 Lic. # 1767 |
11/22/2022 |
| SKYSONA elivaldogene autotemcel |
Indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD). | 125755/0 | bluebird bio, Inc. 455 Grand Union Blvd Somerville, MA 02145 Lic. # 2160 |
09/16/2022 |
| ZYNTEGLO betibeglogene autotemcel |
Indicated for the treatment of adult and pediatric patients with ß-thalassemia who require regular red blood cell (RBC) transfusions. | 125717/0 | bluebird bio, Inc. 455 Grand Union Blvd Somerville, MA 02145 Lic. # 2160 |
08/17/2022 |
| Alinity s Anti-HCV II Reagent Kit Hepatitis C Virus (E coli, Recombinant) NS3 Helicase Antigens and Synthetic Core Peptide |
Intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti- HCV. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing serum and EDTA plasma specimens to screen cadaveric (nonheart- beating) donors. It is not intended for use on cord blood specimens. | 125759/0 | Abbott GmbH Abbott Laboratories Dept T3M2, Bldg. AP20 100 Abbott Park Road Abbott Park, IL 60064 Lic. # 2095 |
07/15/2022 |
| PRIORIX Measles, Mumps and Rubella Vaccine Live |
Indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older. | 125748/0 | GlaxoSmithKline Biologicals SA 1250 South Collegeville Road Collegeville, PA 19426 Lic. # 1617 |
06/03/2022 |
| DG Gel 8 Direct Coombs (Anti-IgG, -C3d) Anti-Human Globulin (Rabbit/Murine Monoclonal) |
Indicated for use with the DG Gel System to detect in vivo coating of human red blood cells with IgG and C3d (direct antiglobulin test). | 125705/0 | Diagnostic Grifols, S.A. Avda. de la Gerneralitat, 152 Sant Cugat del Valles Barcelona 08174 Spain Lic. # 1887 |
05/20/2022 |
| Anti-Human Globulin Anti-C3d FFMU, Murine Monoclonal Anti-Human Globulin (Murine Monoclonal) (For Further Manufacturing Use) |
Indicated for further manufacturing use in the production of Anti-IgG, -C3d Anti-Human Globulin under a Shared Manufacturing Agreement with Diagnostic Grifols, S.A. | 125707/0 | Diagast NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426 Lic. # 1744 |
05/20/2022 |
| Anti-Human Globulin Anti-C3d FFMU, Murine Monoclonal Anti-Human Globulin (Murine Monoclonal) (For Further Manufacturing Use) |
Indicated for further manufacturing use in the production of Anti-IgG, -C3d Anti-Human Globulin under a Shared Manufacturing Agreement with Diagnostic Grifols, S.A. | 125708/0 | Diagast NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426 Lic. # 1744 |
05/20/2022 |
| DG Gel 8 Direct Coombs (Anti-C3d) Anti-Human Globulin (Murine Monoclonal) |
Indicated for use with the DG Gel System to detect in vivo coating of human red blood cells with C3d (direct antiglobulin test). | 125711/0 | Diagnostic Grifols, S.A. Avda. de la Gerneralitat, 152 Sant Cugat del Valles Barcelona 08174 Spain Lic. # 1887 |
05/20/2022 |
| CARVYKTI ciltacabtagene autoleucel |
Is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. | 125746/0 | Janssen Biotech, Inc. 920 US Highway 202 P.O. Box 300 Raritan, NJ 08869 Lic. # 1864 |
02/28/2022 |
| SPIKEVAX COVID-19 Vaccine, mRNA |
Active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older | 125752/0 | ModernaTX, Inc. 200 Technology Square Cambridge, MA 02139 Lic. # 2256 |
01/31/2022 |