Optimus Receives Tentative Approval from U.S. FDA for Brexpiprazole Tablets
Optimus Pharma Private Limited today announced that it 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 Co., Ltd. Optimus Pharma’s approval for its Abbreviated New Drug Application (ANDA) BREXPIPRAZOLE Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, was received on October 8th, 2021. BREXPIPRAZOLE will be manufactured at Optimus Pharma’s Pashmylaram USFDA accredited facility in India.
BREXPIPRAZOLE Tablets (RLD: Rexulti® Tablets) had estimated annual sales of USD 1258 million in the U.S. (IQVIA MAT July 2021).
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 (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 major depressive disorder.
About Optimus Pharma
Optimus was established in the year 2004 as custom synthesis laboratory by a team of techno-commercial experts. It is one of the fastest growing Manufacturer in Active Pharmaceutical Ingredients (APIs) and Finished dosages. Over the last decade we have been certified and audited by reputed Global Regulatory Agencies like USFDA, WHO, COFEPRIS, EMA, KFDA and AFM from PMDA Japan. Optimus Pharma is a vertically integrated pharmaceutical company engaged in manufacturing of Solid Oral and semisolid formulations. We have successfully integrated our API and Formulation R&D teams with the IP and Regulatory Affairs team in order to ensure a dynamic product portfolio. We help our customers serve global markets with technology based, innovative, cost effective & consumer friendly products of the highest quality.
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