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.
| Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|---|
| Alyglo immune globulin intravenous, human-stwk |
Indicated for treatment of primary humoral immunodeficiency (PI) in adults. | 125743/0 | GC Biopharma Corp. ------(b)(4)------------------------------------- ------------------------------- Lic. # 2033 |
12/15/2023 |
| Casgevy exagamglogene autotemcel (exa-cel) |
Indicated for treatment of sickle cell disease (SCD) in patients 12 years of age or older with recurrent vaso-occlusive crises (VOCs). | 125787/0 | Vertex Pharmaceuticals Inc 50 Northern Avenue Boston, MA 02210 Lic. # 2279 |
12/08/2023 |
| LYFGENIA lovotibeglogene autotemcel |
Indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events (VOEs). | 125788/0 | bluebird bio, Inc. 455 Grand Union Boulevard Somerville, Massachusetts 02145 Lic. # 2160 |
12/08/2023 |
| ADZYNMA ADAMTS13, recombinant-krhn |
Indicated for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). | 125795/0 | Takeda Pharmaceuticals U.S.A., Inc. 125 Binney Street Cambridge, MA 02142 Lic. # 1898 |
11/09/2023 |
| IXCHIQ Chikungunya Vaccine, Live |
Indicated for active immunization for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. | 125777/0 | Valneva Austria GmbH Valneva USA, Inc. 4550 Montgomery Avenue Bethesda, MD 20814 Lic. # 1909 |
11/09/2023 |
| PENBRAYA Meningococcal Groups A, B, C, W, and Y Vaccine |
Indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. Meningococcal Groups A, B, C, W, and Y Vaccine is approved for use in individuals 10 through 25 years of age. | 125770/0 | Pfizer Ireland Pharmaceuticals Pfizer Inc. 1 Pfizer Way 190/004/4405 Pearl River, NY 10965 Lic. # 2060 |
10/20/2023 |
| Elecsys HTLV- I/II Elecsys HTLV-I/II |
Intended to screen individual human donors, including volunteer donors of whole blood and blood components. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens. | 125792/0 | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 Lic. # 2305 |
10/17/2023 |
| Source Plasma | Indicated for further manufacturing of injectable and non-injectable products. | 125801/0 | DB Biologics LLC 4101 Research Commons 79 T.W. Alexander Drive Research Triangle Park, NC 27709 Lic. # 2327 |
09/13/2023 |
| ABRYSVO Respiratory Syncytial Virus Vaccine |
Indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. | 125768/0 | Pfizer Inc. 500 Arcola Road Collegeville, PA 19426 Lic. # 2001 |
08/21/2023 |
| BALFAXAR prothrombin complex concentrate, human-lans |
Indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure. | 125776/0 | Octapharma Pharmazeutika Produktionsges.m.b.H. Octapharma USA, Inc. 117 West Century Road Paramus, NJ 07652 Lic. # 1646 |
07/21/2023 |
| CYFENDUS Anthrax Vaccine Adsorbed, Adjuvanted |
Indicated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. | 125761/0 | Emergent Product Development Gaithersburg Inc. 300 Professional Drive Gaithersburg, MD 20879 Lic. # 2089 |
07/20/2023 |
| ROCTAVIAN valoctocogene roxaparvovec-rvox |
Valoctocogene roxaparvovec-rvox is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity <1 IU/dL) without pre-existing antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test. | 125720/0 | BioMarin Pharmaceutical Inc. 105 Digital Drive Novato, CA 94949 Lic. # 1649 |
06/29/2023 |
| LANTIDRA donislecel-jujn |
Indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. | 125734/0 | CellTrans Inc. 2201 W. Campbell Park Drive, Suite 23 Chicago, IL 60612 Lic. # 2213 |
06/28/2023 |
| ELEVIDYS delandistrogene moxeparvovec-rokl |
Indicated for treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. | 125781/0 | Sarepta Therapeutics, Inc. 215 First Street Cambridge, MA 02142 Lic. # 2308 |
06/22/2023 |
| Elecsys HIV Duo Elecsys HIV Duo |
Elecsys HIV Duo is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens. | 125778/0 | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 Lic. # 2305 |
06/13/2023 |
| 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 |
| 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 |
| 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 |
| 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 |