2024 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 |
|---|---|---|---|---|
| GAMMAGARD LIQUID Immune Globulin Infusion (Human) |
To improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). | 125105/2023 | Takeda Pharmaceuticals U.S.A., Inc. 650 E. Kendall Street Cambridge, MA 02142 Lic. # 1898 |
01/26/2024 |
| HYQVIA Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase |
For treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. | 125402/885 | Takeda Pharmaceuticals U.S.A., Inc. 650 E. Kendall Street Cambridge, MA 02142 Lic. # 1898 |
01/12/2024 |