PITTSBURGH and BANGALORE, India, Sept. 5, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced U.S. Food and Drug Administration (FDA) tentative approval for a New Drug Application for abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension for the treatment of HIV-1 infection in paediatric patients.
The South African Health Products Regulatory Authority (SAHPRA) has approved a sweet-tasting, heat-stable, ‘4-in-1’ fixed-dose combination of four antiretroviral (ARV) treatments composed of abacavir, lamivudine, lopinavir, and ritonavir that is specifically designed for infants and young children with HIV. This combination treatment has been developed by Cipla and the not-for-profit Drugs for Neglected Diseases initiative (DNDi).
ViiV Healthcare Announces US FDA Approval of Cabenuva (cabotegravir, rilpivirine) for Virologically Suppressed Adolescents Living With HIV Who Are 12 Years of Age or Older and Weigh at Least 35 kg
ViiV Healthcare, the global specialist HIV company majority-owned by GSK with Pfizer Inc. and Shionogi Limited as shareholders, has announced it has made a regulatory submission to the US Food and Drug Administration (FDA) for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine and, to extend its current approval for Triumeq (abacavir/ dolutegravir/lamivudine) to lower the minimum weight at which a child can be prescribed this medicine, from 40kg and above to 14kg and above. If approved, this approval will result in further treatment options for younger children living with HIV.
ViiV Healthcare, the global specialist HIV company majority-owned by GSK with Pfizer Inc. and Shionogi Limited as shareholders, has announced it has made a regulatory submission to the US Food and Drug Administration (FDA) for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine and, to extend its current approval for Triumeq (abacavir/ dolutegravir/lamivudine) to lower the minimum weight at which a child can be prescribed this medicine, from 40kg and above to 14kg and above. If approved, this approval will result in further treatment options for younger children living with HIV.
The U.S. FDA compiles a list of off-patent drugs without an approved generic to encourage the development of copycats. Now, the Chinese authorities are rolling out a similar initiative, only with some extra incentives.
Laurus Labs Generic Abacavir; Dolutegravir;Lamivudine Receives Tentative Approval in US
Apotex Research Private Limited On FDA Import Alert List
Less than a month after claiming FDA approval for its new HIV therapy Biktarvy, Gilead Sciences has reported new data claiming patients can safely switch to its drug from rival ViiV Healthcare’s Triumeq.
PREZISTA® (darunavir): JANSSEN PRODUCTS, L.P., and )nJANSSEN SCIENCES IRELAND UC, v.AUROBINDO PHARMA LTD., and )nAUROBINDO PHARMA USA INC.