Drug firm Alembic Pharmaceuticals said it has received approval from the US health regulator for Pramipexole Dihydrochloride extended-release tablets used for the treatment of Parkinson’s disease.
The approval from the United States Food and Drug Administration (USFDA) is for the company’s abbreviated new drug application (ANDA) for Pramipexole Dihydrochloride extended-release tablets, in the strengths of 0.375 milligram (mg), 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg, Alembic Pharmaceuticals said in a filing to Bombay Stock Exchange (BSE).
The approved product is a therapeutic equivalent to the reference listed drug product (RLD) Mirapex ER tablets, of Boehringer lngelheim Pharmaceuticals Inc.
Quoting IQVIA data, Alembic Pharma said Pramipexole Dihydrochloride extended-release tablets have an estimated market size of $38.6 million for twelve months ending December 2017.
The company currently has a total of 84 ANDA approvals (71 final approvals and 13 tentative approvals) from USFDA, it added.
Shares of Alembic Pharmaceuticals were trading at Rs 587.05 apiece on BSE, up 1.04 per cent from its previous close.