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Gilead receives FDA approval for lower-dose HIV drug in children
FOSTER CITY, Calif. — The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.
Gilead announced the FDA approval of Viread (tenofovir disoproxil fumarate) in the 150-mg, 200-mg and 250-mg strengths combined with other antiretroviral drugs in patients ages 6 to 12 years while also approving an oral powder formulation for children ages 2 to 5 years. The agency approved the drug in the 300-mg strength for adults in 2001 and for patients ages 12 to 17 years in 2010.
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Sandoz starts two late-stage biosimilar trials
HOLZKIRCHEN, Germany — Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.