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Novartis/Orion triple-combo Parkinson’s submission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis and Orion Pharma submit NDA for first triple-combination Parkinson's disease therapy, the firms announce Aug. 26. The combination adds entacapone (Orion's Comtan) to the standard regimen for Parkinson's: levodopa and carbidopa. Entacapone, which is approved for patients with idiopathic Parkinson's disease who experience signs and symptoms of end-of-dose "wearing off," reduces the breakdown of levodopa, allowing it to remain therapeutically available for longer periods between doses. A triple-combination product would provide more convenient dosing, the firms sa
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