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 |
|---|---|---|---|---|
| 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 |