FDA Grants Additional Six Months Marketing Exclusivity For The High Blood Pressure Medicine Diovan(R)

 

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.

FDA Grants Additional Six Months Marketing Exclusivity For The High Blood Pressure Medicine Diovan(R)