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27 September, 2024
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5201
Submission : 1984-01-03
Status : Inactive
Type : II
CEP/COS
Certificate Numbers : R1-CEP 2007-227 - Rev 04
Status : Withdrawn by Holder
Issue Date : 2021-02-11
Type : Chemical
Substance Number : 578
CEP/COS
Certificate Numbers : R1-CEP 2004-227 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2019-04-24
Type : Chemical
Substance Number : 987
CEP/COS
Certificate Numbers : R1-CEP 1999-142 - Rev 05
Status : Withdrawn by Holder
Issue Date : 2019-04-24
Type : Chemical
Substance Number : 1403
Details:
Tyenne (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist, antibody indicated for treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis & cytokine release syndrome.
Lead Product(s): Tocilizumab
Therapeutic Area: Immunology Brand Name: Tyenne
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 15, 2024
Lead Product(s) : Tocilizumab
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®, its Third Approv...
Details : Tyenne (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist, antibody indicated for treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis & cytokine release sy...
Brand Name : Tyenne
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 15, 2024
Details:
Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma.
Lead Product(s): Plerixafor
Therapeutic Area: Oncology Brand Name: Mozobil-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 09, 2023
Lead Product(s) : Plerixafor
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Fresenius Kabi Launches Plerixafor Injection
Details : Plerixafor Injection is a hematopoietic stem cell mobilizer used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma.
Brand Name : Mozobil-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 09, 2023
Details:
FYB202 (ustekinumab biosimilar) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders.
Lead Product(s): Ustekinumab
Therapeutic Area: Dermatology Brand Name: FYB202
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Formycon
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2023
Lead Product(s) : Ustekinumab
Therapeutic Area : Dermatology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Formycon
Deal Size : Not Applicable
Deal Type : Not Applicable
Fresenius Kabi and Formycon Secure U.S. License Date for Proposed Ustekinumab Biosimilar
Details : FYB202 (ustekinumab biosimilar) is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders.
Brand Name : FYB202
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 07, 2023
Details:
Idacio (adalimumab-aacf) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface.
Lead Product(s): Adalimumab-aacf
Therapeutic Area: Immunology Brand Name: Idacio
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 03, 2023
Lead Product(s) : Adalimumab-aacf
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Fresenius Kabi Launches its Citrate-free Biosimilar Ldacio (adalimumab-aacf) in the United States
Details : Idacio (adalimumab-aacf) is a biosimilar product of HUMIRA®, formulated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritisetc. The drug bind specifically to TNF-alpha and block its interaction with the p55 and p7...
Brand Name : Idacio
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 03, 2023
Details:
mAbxience has developed and manufactured biological drugs, with commercialized biosimilar product Novex® (rituximab), through its in-house biosimilars programs and through its investment in mAbxience, Fresenius expects rapid growth in biopharmaceutical market.
Lead Product(s): Rituximab
Therapeutic Area: Oncology Brand Name: Novex
Study Phase: ApprovedProduct Type: Large molecule
Recipient: Mabxience
Deal Size: $553.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition August 01, 2022
Details : mAbxience has developed and manufactured biological drugs, with commercialized biosimilar product Novex® (rituximab), through its in-house biosimilars programs and through its investment in mAbxience, Fresenius expects rapid growth in biopharmaceutical ...
Brand Name : Novex
Molecule Type : Large molecule
Upfront Cash : Undisclosed
August 01, 2022
Details:
Bortezomib, a new generic equivalent to Velcade® in U.S, is available in a 3.5 mg per 10mL single-dose vial presentation for subcutaneous or intravenous use, a treatment option for adult patients with multiple myeloma and mantle cell lymphoma.
Lead Product(s): Bortezomib
Therapeutic Area: Oncology Brand Name: Bortezomib-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2022
Lead Product(s) : Bortezomib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Fresenius Kabi Introduces New Generic for the Treatment of Multiple Myeloma
Details : Bortezomib, a new generic equivalent to Velcade® in U.S, is available in a 3.5 mg per 10mL single-dose vial presentation for subcutaneous or intravenous use, a treatment option for adult patients with multiple myeloma and mantle cell lymphoma.
Brand Name : Bortezomib-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 02, 2022
Details:
mAbxience has developed and manufactured biological drugs, with commercialized biosimilar product Novex® (Rituximab), through its in-house biosimilars programs and through its investment in mAbxience Fresenius expects rapid growth in biopharmaceutical market.
Lead Product(s): Rituximab,Cyclophosphamide,Doxorubicin Hydrochloride
Therapeutic Area: Oncology Brand Name: Novex
Study Phase: ApprovedProduct Type: Large molecule
Recipient: Mabxience
Deal Size: $553.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition March 31, 2022
Lead Product(s) : Rituximab,Cyclophosphamide,Doxorubicin Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Approved
Recipient : Mabxience
Deal Size : $553.0 million
Deal Type : Acquisition
Fresenius Kabi Buys a Majority Stake In mAbxience
Details : mAbxience has developed and manufactured biological drugs, with commercialized biosimilar product Novex® (Rituximab), through its in-house biosimilars programs and through its investment in mAbxience Fresenius expects rapid growth in biopharmaceutical m...
Brand Name : Novex
Molecule Type : Large molecule
Upfront Cash : Undisclosed
March 31, 2022
Details:
Icatibant injection is therapeutically equivalent to Firazyr®, and supplied as a 3 mL prefilled, single-use syringe that is self-administered subcutaneously into the abdominal area.
Lead Product(s): Icatibant Acetate
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2020
Lead Product(s) : Icatibant Acetate
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Icatibant injection is therapeutically equivalent to Firazyr®, and supplied as a 3 mL prefilled, single-use syringe that is self-administered subcutaneously into the abdominal area.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 01, 2020
Details:
Fresenius Kabi will have the exclusive right to distribute and sell Veltassa® across China. By bringing Veltassa® to China, VFMCRP and Fresenius Kabi will deliver a treatment that will enable patients to remain on RAASi therapy by managing their chronic hyperkalemia.
Lead Product(s): Patiromer
Therapeutic Area: Nephrology Brand Name: Veltassa
Study Phase: ApprovedProduct Type: Small molecule
Recipient: CSL Vifor
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration November 19, 2020
Lead Product(s) : Patiromer
Therapeutic Area : Nephrology
Highest Development Status : Approved
Recipient : CSL Vifor
Deal Size : Undisclosed
Deal Type : Collaboration
VFMCRP and Fresenius Kabi Expand Collaboration in Nephrology in China with Veltassa® Agreement
Details : Fresenius Kabi will have the exclusive right to distribute and sell Veltassa® across China. By bringing Veltassa® to China, VFMCRP and Fresenius Kabi will deliver a treatment that will enable patients to remain on RAASi therapy by managing their chroni...
Brand Name : Veltassa
Molecule Type : Small molecule
Upfront Cash : Undisclosed
November 19, 2020
Details:
Premier with Fresenius Kabi aims at supplying pre-filled, single-use IV bags of heparin sodium injection, USP to healthcare providers, helping to stabilize the long-term supply of a medication that is necessary when performing a number of hospital inpatient procedures.
Lead Product(s): Heparin Sodium
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Premier
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership November 18, 2020
Lead Product(s) : Heparin Sodium
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Recipient : Premier
Deal Size : Undisclosed
Deal Type : Partnership
ProvideGx® Partners with Fresenius Kabi to Help Stabilize Supply of Heparin
Details : Premier with Fresenius Kabi aims at supplying pre-filled, single-use IV bags of heparin sodium injection, USP to healthcare providers, helping to stabilize the long-term supply of a medication that is necessary when performing a number of hospital inpati...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
November 18, 2020
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