MUMBAI, BALTIMORE — Lupin announced today that it has received final approval for its Tetrabenazine tablets, 12.5 mg and 25 mg from the United States Food and Drug Administration (FDA) to market a generic version of Valeant Pharmaceuticals North America’s  Xenazine tablets, 12.5 mg and 25 mg. These are used for the treatment of chorea associated with Huntington’s disease.

Lupin’s Tetrabenazine tablets, 12.5 mg and 25 mg are the generic equivalent of Valeant Pharmaceuticals North America, LLC’s Xenazine Tablets, 12.5 mg and 25 mg. It is indicated for the treatment of chorea associated with Huntington’s disease.

Tetrabenazine tablets, 12.5 mg and 25 mg had annual sales of approximately $288.1 million in the US (IQVIA MAT January 2018).