Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Abacavir,Dolutegravir Sodium,Lamivudine
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 05, 2023
Lead Product(s) : Abacavir,Dolutegravir Sodium,Lamivudine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Rilpivirine,Zidovudine,Abacavir
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Janssen Submits NDA to FDA for Expanded Pediatric Indication for EDURANT®
Details : Edurant (rilpivirine) is a HIV-1 specific, nonnucleoside reverse transcriptase inhibitor (NNRTI). It is being evaluated for the treatment of HIV-1 infection in children weighing 10 kg or more.
Brand Name : Edurant
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 28, 2023
Lead Product(s) : Rilpivirine,Zidovudine,Abacavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Abacavir,Lamivudine,Lopinavir
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : ABC/3TC/LPV/r
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 14, 2022
Lead Product(s) : Abacavir,Lamivudine,Lopinavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dolutegravir Sodium,Lamivudine,Abacavir
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : Triumeq
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 30, 2022
Lead Product(s) : Dolutegravir Sodium,Lamivudine,Abacavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Abacavir,Dolutegravir Sodium,Lamivudine
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Pfizer Inc
Deal Size : Not Applicable
Deal Type : Not Applicable
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-midd...
Brand Name : Triumeq
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 30, 2022
Lead Product(s) : Abacavir,Dolutegravir Sodium,Lamivudine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Pfizer Inc
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dolutegravir Sodium,Lamivudine,Abacavir
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : 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.
Brand Name : Triumeq
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 04, 2021
Lead Product(s) : Dolutegravir Sodium,Lamivudine,Abacavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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