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Alembic Pharma gets USFDA nod for Parkinson's disease treatment drug

PTI | New Delhi | Updated: 06-06-2019 15:46 IST | Created: 06-06-2019 15:34 IST
Alembic Pharma gets USFDA nod for Parkinson's disease treatment drug
Image Credit: Pixabay

Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for Carbidopa and Levodopa extended-release tablets, used for the treatment of Parkinson's disease. The approved product is therapeutically equivalent to the reference listed drug Sinemet CR tablets of Merck Sharp & Dohme Corp.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application Carbidopa and Levodopa extended-release tablets in the strengths of 25 mg/100 mg and 50mg/200 mg, Alembic said in a BSE filing. Quoting IQVIA sales data, the company said the Carbidopa and Levodopa extended-release tablets had an estimated market size of USD 24 million for 12 months ended December 2018.

The company said it now has a total of 94 abbreviated new drug application (ANDA) approvals from the USFDA. Shares of Alembic Pharmaceuticals were trading at Rs 511.05 apiece, down 0.08 per cent, on the BSE.


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