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April 21, 2021Diovan Receives Expanded Approval
April 21, 2021 – The U.S. FDA has approved an expanded indication for Diovan® (valsartan) oral tablets, manufactured by Novartis, to treat hypertension in patients who are at least one year of age. Previously, the drug was approved only for use in patients at least six years of age.
Hypertension (high blood pressure) in children under the age of six is most often caused by another medical condition such as heart and kidney disease as well as genetic and hormonal diseases.
The recommended starting dose of Diovan for pediatric patients is 1mg/kg of body weight, up to a total dose of 40mg, once daily. In select cases where a greater reduction in blood pressure is needed, a higher starting dose of 2mg/kg may be appropriate. The patient’s dose should be adjusted according to blood pressure response and tolerability of the medication, and should not exceed 4mg/kg a day, up to a maximum of 160mg per day.
A black box warning cautions that Diovan carries a risk of fetal toxicity.