Lupin gets tentative nod from USFDA to market generic Brexpiprazole tablets

Drug firm Lupin on Wednesday said it has received tentative nod from the US health regulator to market generic Brexpiprazole tablets, which are used with anti-depressant medicines for the treatment of major depressive disorder, in the American market.

The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market generic Brexpiprazole tablets in the strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, Lupin said in a regulatory filing.

The product is a generic version of Otsuka Pharmaceutical Co Ltd's Rexulti tablets in the same strengths, it added.

These tablets will be manufactured at the company's Plthampur facility, Lupin said.

Brexpiprazole tablets are indicated for use as an adjunctive therapy to anti-depressants for the treatment of major depressive disorder (MDD) and for treatment of schizophrenia.

As per IQVIA MAT July 2021 data, Brexpiprazole tablets had estimated annual sales of USD 1,258 million in the US, it added.

Shares of Lupin Ltd closed at Rs 947.65 per scrip on the BSE, down 1.65 per cent from their previous close.