2023 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 |
---|---|---|---|---|
AREXVY Respiratory Syncytial Virus Vaccine, Adjuvanted |
Indicated for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older. | 125775/0 | GlaxoSmithKline Biologicals 14200 Shady Grove Road Rockville, MD 20850 Lic. # 1617 |
05/03/2023 |
VYJUVEK beremagene geperpavec-svdt |
Indicated for treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. | 125774/0 | Krystal Biotech, Inc. 2100 Wharton Street, Suite 701 Pittsburgh, PA 15203 Lic. # 2301 |
05/19/2023 |
ABRYSVO Respiratory Syncytial Virus Vaccine |
Indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. | 125769/0 | Pfizer Inc. 500 Arcola Road Collegeville, PA 19426 Lic. # 2001 |
05/31/2023 |
VOWST fecal microbiota spores, live-brpk |
To prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI). | 125757/0 | Seres Therapeutics, Inc. 200 Sidney Street Cambridge, MA 02139 Lic. # 2262 |
04/26/2023 |
OMISIRGE omidubicel-onlv |
Indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. | 125738/0 | Gamida Cell Ltd. 116 Huntington Ave., 7th floor Boston, MA 02116 Lic. # 2223 |
04/17/2023 |
Source Plasma | Indicated for further manufacturing of injectable and non-injectable products. | 125790/0 | Clinical Research Technologies, Inc. (CRT) 1068 Broadway El Cajon, CA 92021 Lic. # 2316 |
02/23/2023 |
ALTUVIIIO antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl |
Indicated for use in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: (1) Routine prophylaxis to reduce the frequency of bleeding episodes; (2) On-demand treatment and control of bleeding episodes; and (3) Perioperative management of bleeding. | 125771/0 | Bioverativ Therapeutics, Inc. 55 Corporate Drive Bridgewater, NJ 08807 Lic. # 2078 |
02/22/2023 |
Source Plasma | Indicated for further manufacturing of injectable products | 125762/0 | Join Parachute, LLC 210 Barton Springs Drive, #550 Austin, TX 78704 Lic. # 2273 |
01/25/2023 |
Source Plasma | Indicated for further manufacturing of injectable and noninjectable products | 125767/0 | Olgam Life LLC 1104 Fulton Street Brooklyn, NY 11238 Lic. # 2287 |
01/19/2023 |
Source Plasma | Indicated for further manufacturing of injectable products | 125765/0 | Pelican Plasma 8910 Linwood Avenue Shreveport, LA 71106 Lic. # 2283 |
01/17/2023 |