Optimus gets USFDA tentative nod for Brexpiprazole tablets

October 10, 2021 07:37 pm | Updated 07:37 pm IST - HYDERABAD

Optimus Pharma has received tentative approval from United States Food and Drug Administration (USFDA) for a generic equivalent of Rexulti tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg of Otsuka Pharmaceutical.

Announcing the approval for its abbreviated new drug application for Brexpiprazole Tablets, in the strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, was received on Friday, the company said it will be manufacturing the product at its Pashmylaram USFDA accredited facility here.

Brexpiprazole tablets had estimated annual sales of $1258 million in the U.S, the company said citing IQVIA numbers. From studies conducted so far, it can be concluded that Brexpiprazole can be an effective monotherapy for schizophrenia and an adjunct to other antidepressant medications in major depressive disorder, it said.

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