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[{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare Submits FDA Application for First Dispersible Single Tablet Regimen Containing Dolutegravir (DTG) For Children Living with HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Pfizer Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Viiv Healthcare Announces US FDA Approval of Triumeq PD, the First Dispersible Single Tablet Regimen Containing Dolutegravir, a Once-daily Treatment for Children Living With HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare Announces U.S.FDA Approval of Triumeq PD, the First Dispersible Single Tablet Regimen Containing Dolutegravir, a Once-daily Treatment for Children Living With HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Cipla","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cipla and DNDi Launch Child-Friendly 4-in-1 Antiretroviral Treatment for Young Children Living with HIV in South Africa","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Viatris","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)\/Dolutegravir (DTG)\/Lamivudine (3TC), a Once-daily Treatment for Children Living with HIV","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"}]

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            The fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension is indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 6 kg.

            Lead Product(s): Abacavir,Dolutegravir Sodium,Lamivudine

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 05, 2023

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            Details:

            The ‘4-in-1’ combination contains an antiretroviral combination of Abacavir, as an alternative first-line regimen for infants and young children with HIV – in the form of granule-filled capsules.

            Lead Product(s): Abacavir,Lamivudine,Lopinavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: ABC/3TC/LPV/r

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 14, 2022

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            In addition, a supplemental new drug application (sNDA) has been approved for Triumeq tablet, lowering the minimum weight that a child with human immunodeficiency virus type 1 (HIV-1) can be prescribed this medicine to 25kgs from 40kgs.

            Lead Product(s): Dolutegravir Sodium,Lamivudine,Abacavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Triumeq

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 30, 2022

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            Details:

            ViiV Healthcare enables generic versions of dolutegravir to be manufactured and sold royalty-free for the treatment of children living with HIV in all least-developed, low-income, lower-middle-income and sub-Saharan Africa countries, also some upper-middle-income countries.

            Lead Product(s): Abacavir,Dolutegravir Sodium,Lamivudine

            Therapeutic Area: Infections and Infectious Diseases Product Name: Triumeq

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Pfizer Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 30, 2022

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            New dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine to extend its current approval for Triumeq for younger children living with HIV.

            Lead Product(s): Dolutegravir Sodium,Lamivudine,Abacavir

            Therapeutic Area: Infections and Infectious Diseases Product Name: Triumeq

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 04, 2021

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