Fennec Pharmaceuticals, Inc. |
73077001001 |
PEDMARK (sodium thiosulfate injection), 12.5 g/100 mL, 100 mL vial |
2022-10-11 |
11417.0900 |
None |
1 |
3480 |
1 |
1 |
None |
None |
None |
None |
PEDMARK was not aquired. Comment regarding to patient estimate - Cisplatin carries the highest risk of ototoxicity among all FDA-approved platinum compounds1. About 5000 children (=18 years) are diagnosed with a solid tumor and treated with platinum-based chemotherapy every year in the United States.2,3 About 70% of these patients (~3500) are diagnosed with localized, non-metastatic disease.4 (1. Langer T et al. Trends Pharmacol Sci. 2013;34(8):458-469. 2. Ward E et al. CA Cancer J Clin. 2014;64(2):83-103. 3. National Cancer Institute. Standard populations – 19 age groups. Accessed June 10, 2022. https://seer.cancer.gov/stdpopulations/stdpop.19ages.html 4. Perkins SM et al. PLoS One. 2014;9(7):e100396. 5. Camet ML et al. Front Oncol. 2021;11:673080. FDA, US Food and Drug Administration). We estimate approximately 290 patients on a monthly based in the United States. |
None |
Fresenius Kabi USA LLC |
63323092688 |
romiDEPsin Intravenous Solution Reconstituted 10 MG |
2022-02-07 |
3168.6500 |
None |
1 |
216 |
None |
None |
None |
None |
None |
None |
None |
None |
Fresenius Kabi USA LLC |
65219038030 |
Allopurinol Sodium Intravenous Solution Reconstituted 500 MG |
2022-05-17 |
2900.0000 |
None |
1 |
2000 |
None |
None |
None |
None |
None |
None |
None |
None |
Fresenius Kabi USA LLC |
63323013410 |
PEMEtrexed Disodium Intravenous Solution Reconstituted 100 MG |
2022-05-24 |
125.0000 |
None |
1 |
788000 |
None |
None |
None |
None |
None |
None |
None |
None |
Fresenius Kabi USA LLC |
63323045050 |
PEMEtrexed Disodium Intravenous Solution Reconstituted 500 MG |
2022-05-24 |
625.0000 |
None |
1 |
788000 |
None |
None |
None |
None |
None |
None |
None |
None |
Fresenius Kabi USA LLC |
65219038110 |
Iodixanol Inj 270 MG/ML (Iodine Equivalent), 100 ML, Unit-Dose, Bottle Qty 10 |
2022-07-15 |
1021.3000 |
None |
1 |
479000 |
None |
None |
None |
None |
None |
None |
None |
None |
Fresenius Kabi USA LLC |
65219038150 |
Iodixanol Inj 270 MG/ML (Iodine Equivalent), 150 ML, Unit-Dose, Bottle Qty 10 |
2022-07-15 |
1489.6000 |
None |
1 |
479000 |
None |
None |
None |
None |
None |
None |
None |
None |
Fresenius Kabi USA LLC |
65219038310 |
Iodixanol Inj 320 MG/ML (Iodine Equivalent), 100 ML, Unit-Dose, Bottle Qty 10 |
2022-07-15 |
1134.9000 |
None |
1 |
479000 |
None |
None |
None |
None |
None |
None |
None |
None |
Fresenius Kabi USA LLC |
65219038350 |
Iodixanol Inj 320 MG/ML (Iodine Equivalent), 150 ML, Unit-Dose, Bottle Qty 10 |
2022-07-15 |
1566.7000 |
None |
1 |
479000 |
None |
None |
None |
None |
None |
None |
None |
None |
Fresenius Kabi USA LLC |
65219038370 |
Iodixanol Inj 320 MG/ML (Iodine Equivalent), 200 ML, Unit-Dose, Bottle Qty 10 |
2022-07-15 |
1930.0000 |
None |
1 |
479000 |
None |
None |
None |
None |
None |
None |
None |
None |
Fresenius Kabi USA LLC |
65219002920 |
Thiotepa For Inj 100 MG, 1 Each, Unit-Dose, Vial |
2022-07-20 |
3000.0000 |
None |
1 |
415000 |
None |
None |
None |
None |
None |
None |
None |
None |
Fresenius Kabi USA LLC |
65219008850 |
Gadoterate Meglumine Intravenous Solution 50 MMOL/100ML |
2022-10-27 |
1084.9800 |
None |
1 |
4165 |
None |
None |
None |
None |
None |
None |
None |
None |
Fresenius Kabi USA LLC |
65219055001 |
PRALAtrexate Intravenous Solution 20 MG/ML |
2022-11-29 |
4981.9700 |
None |
1 |
1420 |
None |
None |
None |
None |
None |
None |
None |
None |
Fresenius Kabi USA LLC |
65219055202 |
PRALAtrexate Intravenous Solution 40 MG/2ML |
2022-11-29 |
9963.9400 |
None |
1 |
713 |
None |
None |
None |
None |
None |
None |
None |
None |