Alembic Pharmaceuticals Ltd has received tentative approval from the US Food and Drug Administration for brexpiprazole tablets in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths, according to an exchange filing.
The drug is a generic version of Otsuka Pharmaceutical Co Ltd's Rexulti tablets.
It is indicated as adjunctive therapy alongside antidepressants for the treatment of major depressive disorders and schizophrenia.
According to information from IQVIA, the drug's sales for the fiscal year that ended in December 2022 totaled about $1.6 billion.
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The shares of the company traded 0.7% higher at ₹515.75 on NSE, at 09:15 IST.
