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

Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for Carbidopa and Levodopa extended-release tablets, used for 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.