ViiV Healthcare Submits Regulatory Applications to the US FDA for a New Dispersible Tablet Formulation of Abacavir/Dolutegravir/Lamivudine to Treat HIV in Children

October 4, 2021 Auto Bot approval, FDA, HIV, regulatory, ViiV Healthcare 0

Shots:

  • ViiV Healthcare has reported a regulatory submission to the US FDA for the approval of a new dispersible tablet formulation of the fixed-dose combination of abacavir, dolutegravir & lamivudine. The submission is based on modeled data and in line with regulatory recommendations
  • The company expands its approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower the minimum weight of the children from ≥40kg to ≥14kg
  • If approved, the therapy will result in additional treatment options for younger children with HIV. Triumeq is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine

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