Novartis Granted Pediatric Indication for Hypertension Treatment

The European Commission (EC) has granted Diovan (valsartan) a pediatric indication for the treatment of hypertension in children and adolescents 6-18 years of age. Following the Commission's decision, the pediatric indication needs to be implemented through EU National Competent Authorities before Diovan will be available for pediatric use across the European Union (EU), both in the existing tablet formulations as well as a newly developed oral solution.

Following national implementation across the EU, Novartis intends to apply for a six-month exclusivity extension of the protection for valsartan (the active ingredient), in line with the European Pediatric Regulation.