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Lupin receives final approval for Tetrabenazine Tablets

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From USFDA

Lupin announced that it has received final approval for its Tetrabenazine Tablets, 125 mg and 25 mg from the United States Food and Drug Administration (FDA) to market a generic version of Valeant pharmaceuticals North America, LLC's Xenazine Tablets, 12.5 mg and 25 mg.

Lupin's Tetrabenazine Tablets, 12.5 mg and 25 mg are the generic equivalent of Va Ie ant 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, 125 mg and 25 mg had annual sales of approximately USD 288.1 million in the US (IQVIA MAT Jan 2018).

 

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First Published: Apr 23 2018 | 1:33 PM IST

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