Lupin receives USFDA’s nod for Brexpiprazole tablets
Drug firm Lupin said it has received approval from the US health regulator for Brexpiprazole tablets used to treat certain mental and mood disorders.
The approval by the US Food and Drug Administration (USFDA) is 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.
The Brexpiprazole tablets are the generic equivalent of Rexulti tablets of Otsuka Pharmaceutical Company Ltd. The product will be manufactured at Lupin’s Pithampur facility in India, it said.
he Brexpiprazole tablets had estimated annual sales of $1,575 million in the US, the company said citing IQVIA MAT December 2022 data.
The company reported a 72 percent decline in consolidated net profit at Rs 153 crore for the third quarter that ended December 31, 2022. The company had reported a net profit of Rs 545 crore for the October-December period last fiscal.
Total revenue from operations however increased to Rs 4,322 crore as compared with Rs 4,161 crore in the year-ago period, the company said in a statement.