Decision is based on pediatric program in hypertension.
Novartis received an additional six months of market exclusivity for its high blood pressure drug, Diovan. The treatment is indicated for use in adults with high blood pressure and heart failure, as well as heart attack survivors.
This extension, which takes patent expiration to September 2012, was based on studies conducted in children with high blood pressure. Novartis says that high blood pressure is reported in 5% of children and adolescents in the U.S. An FDA decision on a possible indication to treat children and adolescents with high blood pressure is anticipated by year end.