API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
0
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
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.
Lead Product(s): Abacavir,Dolutegravir Sodium,Lamivudine
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 05, 2023
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2022
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.
Lead Product(s): Dolutegravir Sodium,Lamivudine,Abacavir
Therapeutic Area: Infections and Infectious Diseases Product Name: Triumeq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2022
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.
Lead Product(s): Dolutegravir Sodium,Lamivudine,Abacavir
Therapeutic Area: Infections and Infectious Diseases Product Name: Triumeq
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021