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Federal Food & Drug Administration Novartis Parkinson's disease Stalevo

FDA appoval

13 Jun, 2003

Novartis announces that the FDA has approved Stalevo (carbidopa, levodopa and entacapone) tablets for patients with idiopathic Parkinson’s disease (PD) who experience signs and symptoms of end-of-dose “wearing off.”┬áStalevo contains levodopa, the most widely used agent for Parkinson’s disease, plus carbidopa and entacapone. While carbidopa reduces the side effects of levodopa, entacapone extends its benefits, permitting Parkinson’s disease patients to have an improved ability to perform everyday tasks and a reduction in symptoms associated with the disease.

Levodopa is recognized as the cornerstone of Parkinson’s disease therapy, but its long-term use is limited by its reduced ability to fully control Parkinson’s disease symptoms. By blocking the enzymatic breakdown of levodopa, Stalevo provides more levodopa to the brain for a longer period of time. Potential patient benefits include more “on” time during which Parkinson’s symptoms are well-controlled and daily activities are improved, and simpler, more convenient dosing.