FDA tentatively approves generic version of pediatric HIV drug under PEPFAR program
05 Sep 2023
Drug ApprovalClinical Study
The FDA on Tuesday tentatively approved a pediatric version of an HIV-1 treatment following a successful public-private partnership between the Clinton Health Access Initiative, Unitaid, GSK’s ViiV Healthcare and two Viatris subsidiaries — Aurobindo and Mylan.
The tentative nod was made as part of the President’s Emergency Plan for AIDS Relief (PEPFAR) scheme, which will make accessible a dispersible formulation of the combo of antivirals abacavir, dolutegravir and lamivudine, for the treatment of HIV-1 infection in pediatric patients at least 3 months old and weighing between 6 kg (13 lbs) and 25 kg (55 lbs) in low- and middle-income countries. No exact date was given for when the drug will launch or win full FDA approval.
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