Lupin gets tentative USFDA approval to market generic valbenazine capsules

Pharmaceuticals firm Lupin Ltd. said it has received tentative approval from the U.S. health regulator to market its generic valbenazine capsules used to treat involuntary movements of the face, tongue, or other body parts.
The approval by the U.S. Food and Drug Administration is for the abbreviated new drug application of valbenazine capsules of strengths 40 mg, 60 mg, and 80 mg, the company said in a regulatory filing.
These are the generic equivalent of Ingrezza capsules, 40 mg, 60 mg, and 80 mg, of Neurocrine Biosciences, Inc., it added.
Valbenazine capsules had estimated annual sales of $1,235 million in the U.S., the company said, citing IQVIA MAT December 2022 data.
Source: Bqprime

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