FDA grants Novartis exclusivitiy for blood pressure medication for children
BASEL, Switzerland Novartis announced that the Food and Drug Administration has granted Diovan (valsartan) pediatric exclusivity based on studies conducted in children with high blood pressure.
Nearly 5 percent of U.S. children and adolescents may have high blood pressure, according to Novartis. The company added that it anticipates an FDA decision on adding a pediatric indication to Diovan’s labeling by the end of the year.
Diovan is Novartis’ top-selling brand drug, with $2.4 billion in sales during the first half of 2007, the company reported in its second-quarter earnings statement last month.