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GSK's ViiV Healthcare Says US FDA Approves Tivicay PD for Pediatric HIV Patients

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GSK's (GSK) majority-owned ViiV Healthcare unit said Wednesday the US Food and Drug Administration has approved Tivicay PD, or dolutegravir, for use with other antiretroviral medicines to treat HIV-1 infection in children weighing at least 2 kilograms, including eligible newborns.

The approval covers treatment-naive or treatment-experienced patients who have not previously received an integrase strand transfer inhibitor, ViiV Healthcare said.

The approval is supported by data that showed dolutegravir reached therapeutic drug levels with a safety profile consistent with that seen in older pediatric and adult patients, the company said.

Price: $51.80, Change: $-0.27, Percent Change: -0.52%

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