Brexpiprazole Optimus receives tentative approval from US FDA for generic Brexpiprazole tablets
Hyderabad/UNI: Optimus Pharma Private Limited Saturday announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for the generic equivalent of Rexulti Tablets in the strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg of Otsuka Pharmaceutical Co. Ltd.
Optimus Pharma’s approval for its Abbreviated New Drug Application (ANDA) Brexpiprazole tablets in the same strengths was received Friday.
These tablets will be manufactured at Optimus Pharma’s Pashmylaram facility accredited to USFDA in India, the pharma company release said.
Brexpiprazole 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 like (extrapyramidal symptoms, metabolic complications, weight gain, akathisia potential) that are commonly encountered with other typical and second-generation antipsychotic drugs.
From the studies done so far, it can be concluded that Brexpiprazole can be an effective monotherapy for Schizophrenia and as an adjunct to other antidepressant medications in a major depressive disorder.
As per IAVIA MAT July data for 2021, Brexpiprazole tablets (RLD: Rexulti Tablets) had estimated annual sales of USD 1,258 million in America.
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