New Delhi: Drug firm Lupin said it has received approval from the US health regulator to market in America its Tetrabenazine tablets used for the treatment of involuntary movements associated with Huntington’s disease.
The company has received final approval to market the 12.5 mg and 25 mg tablets from the United States Food and Drug Administration (USFDA), Lupin said in a filing to BSE.
The tablets are generic version of Valeant Pharmaceuticals North America LLC’s Xenazine tablets in the same strengths, it added.
According to IQVIA MAT Jan 2018 data, Tetrabenazine tablets, 12.5 mg, and 25 mg had annual sales of around $288.1 million in the US, Lupin said.
The product is indicated for the treatment of chorea associated with Huntington’s disease, it added.