Novartis gains pediatric indication for Diovan in EU

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The European Commission (EC) has granted Diovan (valsartan) a new pediatric indication for the treatment of hypertension in children and adolescents 6-18 years of age. 

Following the EC’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, both in the existing tablet formulations as well as a newly developed oral solution.

Following implementation across the EU, the Basel, Switzerland-based Novartis intends to apply for a six-month exclusivity extension of the protection for valsartan, in line with the European Pediatric Regulation.

Diovan also was approved for pediatric use in the U.S. by the FDA in December 2008, for the treatment of children aged 6-16 years with high blood pressure.