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<< 1:31AM Gilead Sciences: FDA approves new formulations of Viread for use by children living with HIV (GILD) 46.26 : Co announces the FDA has approved Viread in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12. The FDA approved a supplemental New Drug Application for three lower-strength once-daily tablets of Viread in doses of 150 mg, 200 mg and 250 mg for children ages 6-12. The agency also approved a New Drug Application for an oral powder formulation of Viread for children ages 2-5. The pediatric regulatory applications for Viread were supported by clinical data from a Phase 3 safety and efficacy study of a Viread-containing antiretroviral regimen compared to an antiretroviral regimen containing zidovudine or stavudine in HIV-infected treatment-experienced children ages 2-12. The safety profile observed in the study was consistent with that observed in clinical trials in adults. The applications were submitted to the FDA on July 18, 2011.