Lupin receives USFDA approval for generic medicine

Pharmaceuticals firm Lupin Ltd on Tuesday said it has received approval from the US health regulator for its generic Brexpiprazole tablets used to treat the symptoms of schizophrenia and depression.

The approval granted by the US Food and Drug Administration (US FDA) is for the abbreviated new drug application for Brexpiprazole tablets of strengths 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, the company said in a regulatory filing.

These are generic equivalent of Rexulti tablets of Otsuka Pharmaceutical Company Ltd, it added.

"This product would be manufactured at Lupin's Pithampur facility in India," the company said.

Lupin said Brexpiprazole tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, had an estimated annual sales of USD 1,575 million in the US, citing IQVIA MAT December 2022 data.