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FDA Expands Label of Oral HIV Drug to Newborns

The label is backed by IMPAACT 2023 data showing therapeutic drug levels in 48 newborns and adds a first second-generation integrase inhibitor option.

Summary by MedPage Today
Dolutegravir is already approved as combination therapy in adults and older children

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Medical Daily broke the news on Wednesday, August 26, 2026.
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