The approved drug is therapeutically equivalent to the reference listed drug Sinemet CR tablets of Merck Sharp and Dohme
Alembic Pharmaceuticals 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 and Dohme.
The company has received approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug application Carbidopa and Levodopa extended-release tablets in the strengths of 25 mg/100 mg and 50 mg/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 US FDA.
Shares of Alembic Pharmaceuticals were trading at Rs 511.05 apiece, down 0.08 per cent, on the BSE.
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