Tag: Optimus Pharma

Optimus Receives Tentative Approval from U.S. FDA for Brexpiprazole Tablets
Business, Press Release

Optimus Receives Tentative Approval from U.S. FDA for Brexpiprazole Tablets

Hyderabad (Telangana) [India], October 09: 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 improveme...