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news.Sun Pharmaceutical's subsidiary has received a tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) to market a generic version of Orion’s Stalevo tablets.
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Stalevo is an anti-parkinsonian dopaminergic combination medication that contains carbidopa, levodopa and entacapone for the treatment of Parkinson’s disease.
The generic carbidopa, levodopa and entacapone tablets contain carbidopa, levodopa and entacapone 25/100/200mg and 37.5/150/200mg.
Stalevo is currently indicated to treat adult patients with idiopathic Parkinson’s disease in two scenarios.