Lupin gets tentative nod from US FDA to market generic Brexpiprazole tablets

Lupin yesterday 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 US Food and Drug Administration (FDA) 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’s Rexulti tablets in the same strengths, it added.

These tablets will be manufactured at the company’s Pithampur 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.