FILGRASTIM Pharmacologic Class Indexing
- Class set ID
- ac4c860c-e0f0-4a33-93ae-6e5e3cd9ccaf
- Version
- 3
- Effective date
- 20231115
- Type
- Indexing - Pharmacologic Class
Mapped DailyMed Labels#
Label, Manufacturer, Effective table| Label | Manufacturer | Effective | SPL version |
|---|
| These highlights do not include all the information needed to use NEUPOGEN safely and effectively. See full prescribing information for NEUPOGEN. NEUPOGEN ® (filgrastim) injection, for subcutaneous or intravenous use Initial U.S. Approval: 1991 | Amgen, Inc | Amgen Manufacturing Limited LLC | 20260308 | 164 |
| These highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI™ (filgrastim-txid) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differ | Tanvex BioPharma USA, Inc. | 20260115 | 5 |
| These highlights do not include all the information needed to use ZARXIO safely and effectively. See full prescribing information for ZARXIO. ZARXIO ® (filgrastim-sndz) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2015 ZARXIO (filgrastim-sndz) is biosimilar* to NEUPOGEN (filgrastim). | Sandoz Inc. | 20250829 | 13 |
| These highlights do not include all the information needed to use NIVESTYM safely and effectively. See full prescribing information for NIVESTYM. NIVESTYM™ (filgrastim-aafi) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2018 NIVESTYM (filgrastim-aafi) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningfu | Pfizer Laboratories Div Pfizer Inc | Hospira Zagreb d.o.o. | Hospira, Inc. | 20250812 | 18 |
| These highlights do not include all the information needed to use NYPOZI safely and effectively. See full prescribing information for NYPOZI. NYPOZI (filgrastim-txid) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 NYPOZI (filgrastim-txid) is biosimilar1 to NEUPOGEN® (filgrastim). Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no c | Cipla USA Inc. | Tanvex BioPharma USA, Inc. | 20250501 | 1 |
| These highlights do not include all the information needed to use RELEUKO safely and effectively. See full prescribing information for RELEUKO. RELEUKO ® (filgrastim-ayow) injection, for subcutaneous or intravenous use. Initial U.S. Approval: 2022 RELEUKO (filgrastim-ayow) is biosimilar* to NEUPOGEN ® (filgrastim) | Amneal Pharmaceuticals LLC | Kashiv BioSciences, LLC | 20250424 | 28 |
| These highlights do not include all the information needed to use GRANIX safely and effectively. See full prescribing information for GRANIX. GRANIX ® (tbo-filgrastim) injection, for subcutaneous use Initial U.S. Approval: 2012 | Cephalon, LLC | 20231130 | 26 |
| 3bc802bd-76b4-4f45-8571-a436ec26228e | Physicians Total Care, Inc. | 20091202 | 1 |