FDA Expands Label of Oral HIV Drug to Newborns

— Dolutegravir is already approved as combination therapy in adults and older children

August 26, 2026

• 2 min read

The FDA expanded the approval of dolutegravir tablets for oral suspension (Tivicay PD) to include newborns with HIV infections younger than 4 weeks of age, the agency announced on Tuesday.

In combination with other antiretroviral therapies (ARTs), the once-daily treatment is indicated for babies weighing at least 2 kg (~4.4 lbs) who are naive to an integrase strand transfer inhibitor (INSTI).

FDA Expands Label of Oral HIV Drug to Newborns

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