Alembic Pharma gets USFDA nod for Parkinson’s disease treatment drugs


Alembic Pharmaceuticals on June 6 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 products are 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 2.5 mg/100 mg and 50mg/200 mg, Alembic said in a BSE filing.

Quoting IQVIA sales data, the company said the two products 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 percent, on the BSE.