Lupin gets FDA approval for drug to treat Parkinson disease
MUMBAI: Pharma major Lupin on Tuesday said it has received final approval for its carbidopa tablets, used for treatment of idiopathic Parkinson's disease, from the United States Food and Drug Administration (FDA).
"We have received final approval for Carbidopa tablets, 25 mg from the USFDA to market a generic version of Aton Pharma Inc's Lodosyn tablets, 25 mg," a company statement said.
Lupin's carbidopa tablets, 25 mg is indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.
Carbidopa tablets, 25 mg had annual sales of approximately $21.9 million in the US as per IMS MAT June 2017.
Lupin is engaged in developing and delivering a wide range of branded and generic formulations, biotechnology products and APIs globally.