Lupin receives tentative approval from U.S. FDA for Valbenazine Capsules

Lupin receives tentative approval from U.S. FDA for Valbenazine Capsules

Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).

FPJ Web DeskUpdated: Monday, March 27, 2023, 10:40 AM IST
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Lupin receives tentative approval from U.S. FDA for Valbenazine Capsules | Image: Lupin (Representative)

Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Valbenazine Capsules, 40 mg, 60 mg, and 80 mg, to market a generic equivalent of Ingrezza Capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc.

Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).

Lupin shares

Lupin Limited shares on Monday at 10:39 am were at Rs 665.15, up by 3.91 per cent.

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