Optimus receives tentative nod from FDA for generic Brexpiprazole tablets

Hyderabad: Hyderabad-based Optimus Pharma has received tentative approval from the United States Food and Drug Administration (FDA) for the generic equivalent of Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, of Otsuka Pharmaceutical. Brexpiprazole tablets will be manufactured at Optimus Pharma’s Pashamylaram USFDA accredited facility in India. The […]

Hyderabad: Hyderabad-based Optimus Pharma has received tentative approval from the United States Food and Drug Administration (FDA) for the generic equivalent of Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, of Otsuka Pharmaceutical.

Brexpiprazole tablets will be manufactured at Optimus Pharma’s Pashamylaram USFDA accredited facility in India. The drug has an estimated annual sale of $1258 million in the US, as of July 2021.

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The drug has a favourable antipsychotic profile in terms of improvement of cognitive performance and sleep patterns, as well as effects on affective states and potential to treat core symptoms in schizophrenia and major depressive disorder, including cognitive deficits with a low risk of adverse effects that are encountered with other typical and second-generation antipsychotic drugs.

From the studies done so far, it shows that Brexpiprazole can be an effective monotherapy for schizophrenia and as an adjunct to other antidepressant medications in major depressive disorder.

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