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FDA extends approval of Tivicay to treat newborns with HIV
The FDA has extended its approval of dolutegravir tablets for oral suspension to treat newborns with HIV. Dolutegravir tablets (Tivicay, ViiV Healthcare) and dolutegravir tablets for oral suspension (Tivicay PD, ViiV) were previously approved for adults and infants aged at least 4 weeks and weighing 3 kg or more.
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healio.com
FDA extends approval of Tivicay to treat newborns with HIV
The FDA has extended its approval of dolutegravir tablets for oral suspension to treat newborns with HIV. Dolutegravir tablets (Tivicay, ViiV Healthcare) and dolutegravir tablets…
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medpagetoday.com
FDA Expands Label of Oral HIV Drug to Newborns
Dolutegravir is already approved as combination therapy in adults and older children
