Lupin gets tentative USFDA approval to market generic valbenazine capsules

Pharmaceuticals firm Lupin Ltd on Monday said it has received tentative approval from the US 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 US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) 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 USD 1,235 million in the US, the company said, citing IQVIA MAT December 2022 data.