Pertuzumab - Food and Drug Administration

Set ID
bd11614e-4776-4a92-aaca-2bcbb5f710ed
Type
Indexing - product concept
Effective date
2021-01-15
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use TECENTRIQ HYBREZA safely and effectively. See full prescribing information for TECENTRIQ HYBREZA. TECENTRIQ HYBREZA ® (atezolizumab and hyaluronidase-tqjs) injection, for subcutaneous use Initial U.S. Approval: 2024Product nameGenentech, Inc. | Roche Diagnostics GmbH | Genentech, Inc. (Oceanside) | F. Hoffmann-La Roche AG2026-10-13
These highlights do not include all the information needed to use DARZALEX FASPRO safely and effectively. See full prescribing information for DARZALEX FASPRO. DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use Initial U.S. Approval: 2020Product nameJanssen Biotech, Inc. | Eurofins Lancaster Laboratories, LLC | Charles River Laboratories, Inc. | Catalent Indiana, LLC | FUJIFILM Diosynth Biotechnologies Denmark ApS | Janssen Biologics B.V. | Cilag AG | Janssen Sciences Ireland UC | Bioreliance Corporation | Lonza AG | Janssen Pharmaceutica NV2026-10-12
These highlights do not include all the information needed to use HERCESSI safely and effectively. See full prescribing information for HERCESSI. HERCESSI TM (trastuzumab-strf) for injection, for intravenous use Initial U.S. Approval: 2024 HERCESSI TM (trastuzumab-strf) 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 difProduct nameAccord BioPharma Inc. | Shanghai Henlius Biologics Co., Ltd. | Shanghai Henlius Biopharmaceutical Co., Ltd.2026-10-02
These highlights do not include all the information needed to use PHESGO safely and effectively. See full prescribing information for PHESGO. PHESGO ® (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, for subcutaneous use Initial U.S. Approval: 2020Product nameGenentech, Inc. | Roche Diagnostics | F. Hoffmann-La Roche AG | Genentech, Inc. (Oceanside) | Roche Diagnostics GmbH | Roche Singapore Technical Operations Pte. Ltd2026-09-23
These highlights do not include all the information needed to use RITUXAN HYCELA safely and effectively. See full prescribing information for RITUXAN HYCELA. RITUXAN HYCELA ® (rituximab and hyaluronidase human) injection, for subcutaneous use Initial U.S. Approval: 2017Product nameGenentech, Inc. | F. Hoffmann-La Roche AG | Roche Diagnostics GmbH | Genentech, Inc. (Oceanside)2026-09-23
These highlights do not include all the information needed to use HERCEPTIN HYLECTA safely and effectively. See full prescribing information for HERCEPTIN HYLECTA. HERCEPTIN HYLECTA® (trastuzumab and hyaluronidase-oysk) injection, for subcutaneous use Initial U.S. Approval: 2019Product nameGenentech, Inc. | Roche Singapore Technical Operations Pte. Ltd | Roche Diagnostics | Roche Diagnostics GmbH | F. Hoffmann-La Roche AG | Genentech, Inc. (Oceanside)2026-09-22
These highlights do not include all the information needed to use TECENTRIQ HYBREZA safely and effectively. See full prescribing information for TECENTRIQ HYBREZA. TECENTRIQ HYBREZA ® (atezolizumab and hyaluronidase-tqjs) injection, for subcutaneous use Initial U.S. Approval: 2024Product nameGenentech, Inc. | Roche Diagnostics GmbH | Genentech, Inc. (Oceanside) | F. Hoffmann-La Roche AG2026-09-22
These highlights do not include all the information needed to use OCREVUS ZUNOVO safely and effectively. See full prescribing information for OCREVUS ZUNOVO. OCREVUS ZUNOVO ® (ocrelizumab and hyaluronidase-ocsq) injection, for subcutaneous use Initial U.S. Approval: 2024Product nameGenentech, Inc. | Roche Diagnostics GmbH | F. Hoffmann-La Roche AG | Genentech, Inc. (Oceanside) | Roche Diagnostics2026-09-21
These highlights do not include all the information needed to use DARZALEX FASPRO safely and effectively. See full prescribing information for DARZALEX FASPRO. DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use Initial U.S. Approval: 2020Product nameJanssen Biotech, Inc. | Eurofins Lancaster Laboratories, Inc | Charles River Laboratories | Catalent Indiana, LLC | Biogen (Denmark) Manufacturing ApS | Jannsen Biologics B.V. | Cilag AG | Janssen Vaccines Corp. | Janssen Sciences Ireland UC | Bioreliance Corporation | Lonza AG | Janssen Pharmaceutica, NV2026-09-03
These highlights do not include all the information needed to use OCREVUS ZUNOVO safely and effectively. See full prescribing information for OCREVUS ZUNOVO. OCREVUS ZUNOVO ® (ocrelizumab and hyaluronidase-ocsq) injection, for subcutaneous use Initial U.S. Approval: 2024Product nameGenentech, Inc. | Roche Diagnostics GmbH | F. Hoffmann-La Roche AG | Genentech, Inc. (Oceanside) | Roche Diagnostics2026-08-17
These highlights do not include all the information needed to use VYVGART HYTRULO safely and effectively. See full prescribing information for VYVGART HYTRULO. VYVGART HYTRULO ® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U.S. Approval: 2023Product nameargenx US | Patheon Italia SpA | Avid Bioservices Inc. | Vetter RVS | Lonza Biologics Portsmouth | Catalent Indiana, LLC2026-07-15
These highlights do not include all the information needed to use OGIVRI safely and effectively. See full prescribing information for OGIVRI . OGIVRI ® (trastuzumab-dkst) for injection, for intravenous use Initial U.S. Approval: 2017 OGIVRI ® (trastuzumab-dkst) is biosimilar* to HERCEPTIN (trastuzumab).Product nameBiocon Biologics Inc. | Biocon Biologics Limited2026-06-26
These highlights do not include all the information needed to use KANJINTI safely and effectively. See full prescribing information for KANJINTI. KANJINTI ® (trastuzumab-anns) for injection, for intravenous use Initial U.S. Approval: 2019 KANJINTI (trastuzumab-anns) 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 differeProduct nameAmgen, Inc | Amgen Europe BV2026-06-23
These highlights do not include all the information needed to use HYQVIA ® safely and effectively. See full prescribing information for HYQVIA. HYQVIA ® [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] Solution, for subcutaneous administration Initial U.S. Approval: 2014Product nameTakeda Pharmaceuticals America, Inc. | Baxalta Belgium Manufacturing SA | Catalent Indiana, LLC | Takeda Manufacturing Austria AG | Baxalta US Inc.2026-06-18
These highlights do not include all the information needed to use RYBREVANT FASPRO safely and effectively. See full prescribing information for RYBREVANT FASPRO. RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) injection, for subcutaneous use Initial U.S. Approval: 2025Product nameJanssen Biotech, Inc. | Samsung Biologics Co., Ltd. | Janssen Sciences Ireland UC | Jannsen Biologics B.V. | Cilag AG | Bioreliance Corporation | Avid Bioservices Inc.2026-06-17
These highlights do not include all the information needed to use HERCEPTIN HYLECTA safely and effectively. See full prescribing information for HERCEPTIN HYLECTA. HERCEPTIN HYLECTA® (trastuzumab and hyaluronidase-oysk) injection, for subcutaneous use Initial U.S. Approval: 2019Product nameGenentech, Inc. | Roche Singapore Technical Operations Pte. Ltd | Roche Diagnostics | Roche Diagnostics GmbH | F. Hoffmann-La Roche AG | Genentech, Inc. (Oceanside)2026-05-29
These highlights do not include all the information needed to use HERCEPTIN safely and effectively. See full prescribing information for HERCEPTIN. HERCEPTIN ® (trastuzumab) for injection, for intravenous use Initial U.S. Approval: 1998Product nameGenentech, Inc. | Roche Singapore Technical Operations Pte. Ltd | Roche Diagnostics | Roche Diagnostics GmbH | Genentech, Inc. (Hillsboro) | Genentech, Inc. (Oceanside)2026-05-29
These highlights do not include all the information needed to use PHESGO safely and effectively. See full prescribing information for PHESGO. PHESGO ® (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, for subcutaneous use Initial U.S. Approval: 2020Product nameGenentech, Inc. | Roche Diagnostics GmbH | F. Hoffmann-La Roche AG | Genentech, Inc. (Oceanside) | Roche Singapore Technical Operations Pte. Ltd2026-05-21
These highlights do not include all the information needed to use TECENTRIQ HYBREZA safely and effectively. See full prescribing information for TECENTRIQ HYBREZA. TECENTRIQ HYBREZA ® (atezolizumab and hyaluronidase-tqjs) injection, for subcutaneous use Initial U.S. Approval: 2024Product nameGenentech, Inc. | Roche Diagnostics GmbH | Genentech, Inc. (Oceanside) | F. Hoffmann-La Roche AG2026-05-20
These highlights do not include all the information needed to use VYVGART HYTRULO safely and effectively. See full prescribing information for VYVGART HYTRULO. VYVGART HYTRULO ® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U.S. Approval: 2023Product nameargenx US | Patheon Italia SpA | Avid Bioservices Inc. | Vetter RVS | Lonza Biologics Portsmouth | Catalent Indiana, LLC2026-05-13
These highlights do not include all the information needed to use OPDIVO QVANTIG safely and effectively. See full prescribing information for OPDIVO QVANTIG. OPDIVO QVANTIG™ (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous use. Initial U.S. Approval: 2024Product nameE.R. Squibb & Sons, L.L.C. | Bioreliance Ltd.2026-05-12
These highlights do not include all the information needed to use OPDIVO QVANTIG safely and effectively. See full prescribing information for OPDIVO QVANTIG. OPDIVO QVANTIG™ (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous use. Initial U.S. Approval: 2024Product nameE.R. Squibb & Sons, L.L.C. | Bioreliance Ltd.2026-05-12
These highlights do not include all the information needed to use PERJETA safely and effectively. See full prescribing information for PERJETA. PERJETA ® (pertuzumab) injection, for intravenous use Initial U.S. Approval: 2012Product nameGenentech, Inc. | Roche Diagnostics GmbH | F. Hoffmann-La Roche AG | Roche Diagnostics | Genentech, Inc. (Hillsboro) | Genentech, Inc. (Oceanside)2026-04-30
These highlights do not include all the information needed to use OCREVUS ZUNOVO safely and effectively. See full prescribing information for OCREVUS ZUNOVO. OCREVUS ZUNOVO ® (ocrelizumab and hyaluronidase-ocsq) injection, for subcutaneous use Initial U.S. Approval: 2024Product nameGenentech, Inc. | Roche Diagnostics GmbH | F. Hoffmann-La Roche AG | Genentech, Inc. (Oceanside) | Roche Diagnostics2026-04-27
These highlights do not include all the information needed to use ONTRUZANT safely and effectively. See full prescribing information for ONTRUZANT. ONTRUZANT (trastuzumab-dttb) for injection, for intravenous use Initial U.S. Approval: 2019 ONTRUZANT (trastuzumab-dttb) 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 diffeProduct nameOrganon LLC | Samsung Bioepis Co., Ltd.2026-04-20
These highlights do not include all the information needed to use TRAZIMERA safely and effectively. See full prescribing information for TRAZIMERA. TRAZIMERA™ (trastuzumab-qyyp) for injection, for intravenous use Initial U.S. Approval: 2019 TRAZIMERA (trastuzumab-qyyp) 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 diffProduct namePfizer Laboratories Div Pfizer Inc | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Belgium NV | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC2026-04-10
These highlights do not include all the information needed to use KANJINTI safely and effectively. See full prescribing information for KANJINTI. KANJINTI ® (trastuzumab-anns) for injection, for intravenous use Initial U.S. Approval: 2019 KANJINTI (trastuzumab-anns) 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 differeProduct nameAmgen, Inc | Amgen Europe BV2026-03-10
These highlights do not include all the information needed to use VYVGART HYTRULO safely and effectively. See full prescribing information for VYVGART HYTRULO. VYVGART HYTRULO ® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U.S. Approval: 2023Product nameargenx US | Patheon Italia SpA | Avid Bioservices Inc. | Vetter RVS | Lonza Biologics Portsmouth | Catalent Indiana, LLC2026-03-10
These highlights do not include all the information needed to use RYBREVANT FASPRO safely and effectively. See full prescribing information for RYBREVANT FASPRO. RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) injection, for subcutaneous use Initial U.S. Approval: 2025Product nameJanssen Biotech, Inc. | Samsung Biologics Co., Ltd. | Janssen Sciences Ireland UC | Jannsen Biologics B.V. | Cilag AG | Bioreliance Corporation | Avid Bioservices Inc.2026-02-18
These highlights do not include all the information needed to use VYVGART HYTRULO safely and effectively. See full prescribing information for VYVGART HYTRULO. VYVGART HYTRULO ® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U.S. Approval: 2023Product nameargenx US | Patheon Italia SpA | Lonza Biologics Tuas Pte.Ltd. | Avid Bioservices Inc. | Vetter RVS | Lonza Biologics Portsmouth | Catalent Indiana, LLC2026-02-13
These highlights do not include all the information needed to use DARZALEX FASPRO safely and effectively. See full prescribing information for DARZALEX FASPRO. DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use Initial U.S. Approval: 2020Product nameJanssen Biotech, Inc. | Eurofins Lancaster Laboratories, Inc | Charles River Laboratories | Catalent Indiana, LLC | Biogen (Denmark) Manufacturing ApS | Jannsen Biologics B.V. | Cilag AG | Janssen Vaccines Corp. | Janssen Sciences Ireland UC | Bioreliance Corporation2026-02-11
These highlights do not include all the information needed to use DARZALEX FASPRO safely and effectively. See full prescribing information for DARZALEX FASPRO. DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use Initial U.S. Approval: 2020Product nameJanssen Biotech, Inc. | Eurofins Lancaster Laboratories, Inc | Charles River Laboratories | Catalent Indiana, LLC | Biogen (Denmark) Manufacturing ApS | Jannsen Biologics B.V. | Cilag AG | Janssen Vaccines Corp. | Janssen Sciences Ireland UC | Bioreliance Corporation | Lonza AG | Janssen Pharmaceutica, NV2026-02-11
These highlights do not include all the information needed to use HYQVIA ® safely and effectively. See full prescribing information for HYQVIA. HYQVIA ® [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] Solution, for subcutaneous administration Initial U.S. Approval: 2014Product nameTakeda Pharmaceuticals America, Inc. | Baxalta Belgium Manufacturing SA | Catalent Indiana, LLC | Takeda Manufacturing Austria AG | Baxalta US Inc.2026-02-04
These highlights do not include all the information needed to use HERZUMA safely and effectively. See full prescribing information for HERZUMA. HERZUMA ® (trastuzumab-pkrb) for injection, for intravenous use Initial U.S. Approval: 2018 HERZUMA (trastuzumab-pkrb) 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 differencesProduct nameCephalon, Inc. | CELLTRION, Inc.2025-12-22
These highlights do not include all the information needed to use RYBREVANT FASPRO safely and effectively. See full prescribing information for RYBREVANT FASPRO. RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) injection, for subcutaneous use Initial U.S. Approval: 2025Product nameJanssen Biotech, Inc. | Janssen Pharmaceutical Sciences Unlimited Company | Samsung Biologics Co., Ltd. | Janssen Sciences Ireland UC | Jannsen Biologics B.V. | Cilag AG | Bioreliance Corporation | Avid Bioservices Inc.2025-12-17
These highlights do not include all the information needed to use DARZALEX FASPRO safely and effectively. See full prescribing information for DARZALEX FASPRO. DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use Initial U.S. Approval: 2020Product nameJanssen Biotech, Inc. | Eurofins Lancaster Laboratories, Inc | Charles River Laboratories | Catalent Indiana, LLC | Biogen (Denmark) Manufacturing ApS | Jannsen Biologics B.V. | Cilag AG | Janssen Vaccines Corp. | Janssen Sciences Ireland UC | Bioreliance Corporation2025-12-16
These highlights do not include all the information needed to use RITUXAN HYCELA safely and effectively. See full prescribing information for RITUXAN HYCELA. RITUXAN HYCELA ® (rituximab and hyaluronidase human) injection, for subcutaneous use Initial U.S. Approval: 2017Product nameGenentech, Inc. | F. Hoffmann-La Roche AG | Roche Diagnostics GmbH | Genentech, Inc2025-12-15
These highlights do not include all the information needed to use OCREVUS ZUNOVO safely and effectively. See full prescribing information for OCREVUS ZUNOVO. OCREVUS ZUNOVO ® (ocrelizumab and hyaluronidase-ocsq) injection, for subcutaneous use Initial U.S. Approval: 2024Product nameGenentech, Inc. | Roche Diagnostics GmbH | F. Hoffmann-La Roche AG | Roche Singapore Technical Operations Pte. Ltd. | Genentech, Inc. (Oceanside)2025-12-11
These highlights do not include all the information needed to use HERCEPTIN HYLECTA safely and effectively. See full prescribing information for HERCEPTIN HYLECTA. HERCEPTIN HYLECTA® (trastuzumab and hyaluronidase-oysk) injection, for subcutaneous use Initial U.S. Approval: 2019Product nameGenentech, Inc. | Roche Singapore Technical Operations Pte. Ltd | Roche Diagnostics | Roche Diagnostics GmbH | F. Hoffmann-La Roche AG | Genentech, Inc. (Oceanside)2025-12-10
These highlights do not include all the information needed to use PERJETA safely and effectively. See full prescribing information for PERJETA. PERJETA ® (pertuzumab) injection, for intravenous use Initial U.S. Approval: 2012Product nameGenentech, Inc. | Roche Diagnostics GmbH | F. Hoffmann-La Roche AG | Roche Diagnostics | Genentech, Inc. (Hillsboro) | Genentech, Inc. (Oceanside)2025-12-05
These highlights do not include all the information needed to use PHESGO safely and effectively. See full prescribing information for PHESGO. PHESGO ® (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, for subcutaneous use Initial U.S. Approval: 2020Product nameGenentech, Inc. | Roche Diagnostics GmbH | F. Hoffmann-La Roche AG | Genentech, Inc. (Oceanside) | Roche Singapore Technical Operations Pte. Ltd2025-12-05
These highlights do not include all the information needed to use TECENTRIQ HYBREZA safely and effectively. See full prescribing information for TECENTRIQ HYBREZA. TECENTRIQ HYBREZA ® (atezolizumab and hyaluronidase-tqjs) injection, for subcutaneous use Initial U.S. Approval: 2024Product nameGenentech, Inc. | Roche Diagnostics GmbH | Genentech, Inc. (Oceanside) | F. Hoffmann-La Roche AG2025-12-03
These highlights do not include all the information needed to use VYVGART HYTRULO safely and effectively. See full prescribing information for VYVGART HYTRULO. VYVGART HYTRULO ® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U.S. Approval: 2023Product nameargenx US | Patheon Italia SpA | Lonza Biologics Tuas Pte.Ltd. | Avid Bioservices Inc. | Vetter RVS | Lonza Biologics Portsmouth | Catalent Indiana, LLC2025-12-02
These highlights do not include all the information needed to use DARZALEX FASPRO safely and effectively. See full prescribing information for DARZALEX FASPRO. DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use Initial U.S. Approval: 2020Product nameJanssen Biotech, Inc. | Eurofins Lancaster Laboratories, Inc | Charles River Laboratories | Catalent Indiana, LLC | Biogen (Denmark) Manufacturing ApS | Jannsen Biologics B.V. | Cilag AG | Janssen Vaccines Corp. | Janssen Sciences Ireland UC | Bioreliance Corporation2025-11-26
These highlights do not include all the information needed to use HYQVIA ® safely and effectively. See full prescribing information for HYQVIA. HYQVIA ® [Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase] Solution, for subcutaneous administration Initial U.S. Approval: 2014Product nameTakeda Pharmaceuticals America, Inc. | Baxalta Belgium Manufacturing SA | Catalent Indiana, LLC | Takeda Manufacturing Austria AG2025-11-25
These highlights do not include all the information needed to use OPDIVO QVANTIG safely and effectively. See full prescribing information for OPDIVO QVANTIG. OPDIVO QVANTIG™ (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous use. Initial U.S. Approval: 2024Product nameE.R. Squibb & Sons, L.L.C. | BioReliance Ltd.2025-11-24
These highlights do not include all the information needed to use TECENTRIQ HYBREZA safely and effectively. See full prescribing information for TECENTRIQ HYBREZA. TECENTRIQ HYBREZA ® (atezolizumab and hyaluronidase-tqjs) injection, for subcutaneous use Initial U.S. Approval: 2024Product nameGenentech, Inc. | Roche Diagnostics GmbH | Genentech, Inc. (Oceanside) | Roche Diagnostics | F. Hoffmann-La Roche AG2025-11-21
These highlights do not include all the information needed to use DARZALEX FASPRO safely and effectively. See full prescribing information for DARZALEX FASPRO. DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use Initial U.S. Approval: 2020Product nameJanssen Biotech, Inc. | Eurofins Lancaster Laboratories, Inc | Charles River Laboratories | Catalent Indiana, LLC | Biogen (Denmark) Manufacturing ApS | Jannsen Biologics B.V. | Cilag AG | Janssen Vaccines Corp. | Janssen Sciences Ireland UC | Bioreliance Corporation2025-11-11
These highlights do not include all the information needed to use OPDIVO QVANTIG safely and effectively. See full prescribing information for OPDIVO QVANTIG. OPDIVO QVANTIG™ (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous use. Initial U.S. Approval: 2024Product nameE.R. Squibb & Sons, L.L.C.2025-10-27
These highlights do not include all the information needed to use VYVGART HYTRULO safely and effectively. See full prescribing information for VYVGART HYTRULO. VYVGART HYTRULO ® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U.S. Approval: 2023Product nameargenx US | Patheon Italia SpA | Lonza Biologics Tuas Pte.Ltd. | Avid Bioservices Inc. | Vetter RVS | Lonza Biologics Portsmouth | Catalent Indiana, LLC2025-10-21
These highlights do not include all the information needed to use TECENTRIQ HYBREZA safely and effectively. See full prescribing information for TECENTRIQ HYBREZA. TECENTRIQ HYBREZA™ (atezolizumab and hyaluronidase-tqjs) injection, for subcutaneous use Initial U.S. Approval: 2024Product nameGenentech, Inc. | Roche Diagnostics GmbH | Genentech, Inc. (Oceanside) | F. Hoffmann-La Roche Ltd.2025-08-22
These highlights do not include all the information needed to use OPDIVO QVANTIG safely and effectively. See full prescribing information for OPDIVO QVANTIG. OPDIVO QVANTIG™ (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous use. Initial U.S. Approval: 2024Product nameE.R. Squibb & Sons, L.L.C.2025-06-06
These highlights do not include all the information needed to use VYVGART HYTRULO safely and effectively. See full prescribing information for VYVGART HYTRULO. VYVGART HYTRULO ® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U.S. Approval: 2023Product nameargenx US | Patheon Italia SpA | Lonza Biologics Tuas Pte.Ltd. | Avid Bioservices Inc. | Vetter RVS | Lonza Biologics Portsmouth | Catalent Indiana, LLC2025-04-14
These highlights do not include all the information needed to use HERCESSI safely and effectively. See full prescribing information for HERCESSI. HERCESSI TM (trastuzumab-strf) for injection, for intravenous use Initial U.S. Approval: 2024 HERCESSI (trastuzumab-strf) is biosimilar* to HERCEPTIN (trastuzumab).Product nameAccord BioPharma Inc. | Shanghai Henlius Biologics Co., Ltd. | Shanghai Henlius Biopharmaceutical Co., Ltd.2025-03-21
These highlights do not include all the information needed to use OGIVRI safely and effectively. See full prescribing information for OGIVRI . OGIVRI ® (trastuzumab-dkst) for injection, for intravenous use Initial U.S. Approval: 2017 OGIVRI ® (trastuzumab-dkst) is biosimilar* to HERCEPTIN (trastuzumab).Product nameBiocon Biologics Inc. | Biocon Biologics Limited2024-11-30
These highlights do not include all the information needed to use HERCEPTIN safely and effectively. See full prescribing information for HERCEPTIN. HERCEPTIN ® (trastuzumab) for injection, for intravenous use Initial U.S. Approval: 1998Product nameGenentech, Inc. | Roche Singapore Technical Operations Pte. Ltd. | Roche Diagnostics GmbH2024-11-18
These highlights do not include all the information needed to use HYLENEX recombinant safely and effectively. See full prescribing information for HYLENEX recombinant. HYLENEX recombinant (hyaluronidase) injection for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, retrobulbar use, for soft tissue use or for subcutaneous use Initial U.S. Approval: 2005Product nameAntares Pharma, Inc. | Patheon Manufacturing Services LLC2024-11-11
These highlights do not include all the information needed to use HYLENEX recombinant safely and effectively. See full prescribing information for HYLENEX recombinant. HYLENEX recombinant (hyaluronidase human injection) for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, retrobulbar use, for soft tissue use and for subcutaneous use Initial U.S. Approval: 2005Product nameA-S Medication Solutions2023-02-04
HYLENEX® RECOMBINANT 1mL (HYALURONIDASE HUMAN INJECTION) 150 USP UNITS/mL 1mL VIALProduct nameHF Acquisition Co LLC, DBA HealthFirst2021-06-04
These highlights do not include all the information needed to use OGIVRI safely and effectively. See full prescribing information for OGIVRI . OGIVRI ® (trastuzumab-dkst) for injection, for intravenous use Initial U.S. Approval: 2017 OGIVRI ® (trastuzumab-dkst) is biosimilar* to HERCEPTIN (trastuzumab).Product nameMylan Institutional LLC2021-02-08