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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
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.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)

COUNTRY : India

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