ALTUVIIIO |
125771 |
1 |
351(a) |
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl |
For Injection |
Intravenous |
250IU |
Single-Dose Vial |
2023/02/22
|
Bioverativ Therapeutics, Inc. |
Rx |
Licensed |
|
|
ALTUVIIIO |
125771 |
2 |
351(a) |
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl |
For Injection |
Intravenous |
500IU |
Single-Dose Vial |
2023/02/22
|
Bioverativ Therapeutics, Inc. |
Rx |
Licensed |
|
|
ALTUVIIIO |
125771 |
3 |
351(a) |
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl |
For Injection |
Intravenous |
750IU |
Single-Dose Vial |
2023/02/22
|
Bioverativ Therapeutics, Inc. |
Rx |
Licensed |
|
|
ALTUVIIIO |
125771 |
4 |
351(a) |
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl |
For Injection |
Intravenous |
1000IU |
Single-Dose Vial |
2023/02/22
|
Bioverativ Therapeutics, Inc. |
Rx |
Licensed |
|
|
ALTUVIIIO |
125771 |
5 |
351(a) |
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl |
For Injection |
Intravenous |
2000IU |
Single-Dose Vial |
2023/02/22
|
Bioverativ Therapeutics, Inc. |
Rx |
Licensed |
|
|
ALTUVIIIO |
125771 |
6 |
351(a) |
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl |
For Injection |
Intravenous |
3000IU |
Single-Dose Vial |
2023/02/22
|
Bioverativ Therapeutics, Inc. |
Rx |
Licensed |
|
|
ALTUVIIIO |
125771 |
7 |
351(a) |
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl |
For Injection |
Intravenous |
4000IU |
Single-Dose Vial |
2023/02/22
|
Bioverativ Therapeutics, Inc. |
Rx |
Licensed |
|
|
Lamzede |
761278 |
1 |
351(a) |
velmanase alfa-tycv |
For Injection |
Intravenous |
10MG |
Single-Dose Vial |
2023/02/16
|
Chiesi Farmaceutici S.p.A. |
Rx |
Licensed |
|
|
Takhzyro |
761090 |
3 |
351(a) |
lanadelumab-flyo |
Injection |
Subcutaneous |
150MG/1ML (150MG/ML) |
Pre-Filled Syringe |
2023/02/03
|
Takeda Pharmaceuticals U.S.A., Inc. |
Rx |
Licensed |
|
|
Tezspire |
761224 |
3 |
351(a) |
tezepelumab-ekko |
Injection |
Subcutaneous |
210MG/1.91ML (110MG/ML) |
Autoinjector |
2023/02/01
|
AstraZeneca AB |
Rx |
Licensed |
|
|
Leqembi |
761269 |
1 |
351(a) |
lecanemab-irmb |
Injection |
Intravenous |
200MG/2ML (100MG/ML) |
Single-Dose Vial |
2023/01/06
|
Eisai, Incorporated |
Rx |
Licensed |
|
|
Leqembi |
761269 |
2 |
351(a) |
lecanemab-irmb |
Injection |
Intravenous |
500MG/5ML (100MG/ML) |
Single-Dose Vial |
2023/01/06
|
Eisai, Incorporated |
Rx |
Licensed |
|
|
Briumvi |
761238 |
1 |
351(a) |
ublituximab-xiiy |
Injection |
Intravenous |
150MG/6ML (25MG/ML) |
Single-Dose Vial |
2022/12/28
|
TG Therapeutics, Inc. |
Rx |
Licensed |
|
|
Nexobrid |
761192 |
1 |
351(a) |
anacaulase-bcdb |
For Topical Gel |
Topical |
8.8% (1.94GM) |
Single-Use Jar |
2022/12/28
|
MediWound, Ltd. |
Rx |
Licensed |
|
|
Nexobrid |
761192 |
2 |
351(a) |
anacaulase-bcdb |
For Topical Gel |
Topical |
8.8% (4.85GM) |
Single-Use Jar |
2022/12/28
|
MediWound, Ltd. |
Rx |
Licensed |
|
|
Lunsumio |
761263 |
1 |
351(a) |
mosunetuzumab-axgb |
Injection |
Intravenous |
1MG/ML |
Single-Dose Vial |
2022/12/22
|
Genentech, Inc. |
Rx |
Licensed |
|
|
Lunsumio |
761263 |
2 |
351(a) |
mosunetuzumab-axgb |
Injection |
Intravenous |
30MG/30ML (1MG/ML) |
Single-Dose Vial |
2022/12/22
|
Genentech, Inc. |
Rx |
Licensed |
|
|
Adstiladrin |
125700 |
1 |
351(a) |
nadofaragene firadenovec-vncg |
For Suspension |
Intravesical |
3x10^11 viral particles (vp)/mL |
Single-Dose Vial |
2022/12/16
|
Ferring Pharmaceuticals A/S |
Rx |
Licensed |
|
|
Idacio |
761255 |
1 |
351(k) Biosimilar |
adalimumab-aacf |
Injection |
Subcutaneous |
40MG/0.8ML |
Autoinjector |
2022/12/13
|
Fresenius Kabi USA, LLC |
Rx |
Licensed |
adalimumab |
Humira |
Idacio |
761255 |
2 |
351(k) Biosimilar |
adalimumab-aacf |
Injection |
Subcutaneous |
40MG/0.8ML |
Pre-Filled Syringe |
2022/12/13
|
Fresenius Kabi USA, LLC |
Rx |
Licensed |
adalimumab |
Humira |