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FDA Approves Olmesartan Medoxomil for Hypertension in Children, Adolescents NEW YORK -- February 11, 2010 -- The US Food and Drug Administration (FDA) has approved olmesartan medoxomil (Benicar), alone or with other antihypertensive agents, for use in children and adolescents aged 6 to 16 years with hypertension. The approval was based on a phase 3 study examining the antihypertensive effects of olmesartan medoxomil in paediatric patients. The study found olmesartan medoxomil to be safe and efficacious in children aged 6 to 16 years with hypertension, resulting in blood pressure reductions that were superior compared with placebo. Olmesartan medoxomil was generally well tolerated in paediatric patients, and the adverse event profile was similar to that for adults. The only adverse reaction that occurred in >1% of patients treated with olmesartan medoxomil and more frequently than placebo was dizziness. SOURCE: Daiichi Sankyo, Inc. E-mail this page to a friend or colleague! To print, use this version