FDA Grants Additional Six Months Marketing Exclusivity for the High Blood Pressure Medicine Diovan(R).

-- Exclusivity based on pediatric program in hypertension

-- FDA priority review on Diovan high blood pressure indication in children and adolescents expected to be completed by end of year

-- Nearly five percent of children and adolescents in the US may have high blood pressure

EAST HANOVER, N.J., Aug. 10 /PRNewswire/ -- Diovan(R) (valsartan) has been granted pediatric exclusivity by the US Food and Drug Administration (FDA) based on studies conducted in children with high blood pressure. This action extends marketing exclusivity associated with the valsartan compound patent by six months from March to September 2012.

Although high blood pressure is more prevalent in adults (30%)(1), it has been reported that nearly five percent of children and adolescents in the US may have the condition(2). A FDA decision on a possible indication to treat children and adolescents with high blood pressure is anticipated by year end.

"Novartis feels that wherever possible it is important to ensure that medications are studied in patient groups usually excluded from general clinical trials, such as younger people," said James Shannon, MD, Global Head of Development at Novartis Pharma…