Alembic Pharmaceuticals Receives USFDA Tentative Approval for Brexpiprazole Tablets

Alembic Pharmaceuticals Limited has secured tentative approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brexpiprazole Tablets in strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. These tablets are therapeutically equivalent to Otsuk...

Alembic Pharmaceuticals Limited has secured tentative approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brexpiprazole Tablets in strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. These tablets are therapeutically equivalent to Otsuka Pharmaceutical Co.'s Rexulti Tablets and are indicated as an adjunctive therapy to antidepressants for treating major depressive disorder and for the treatment of schizophrenia. According to IQVIA data, the market size for these tablets was approximately $1.6 billion for the twelve months ending December 2022. This approval marks Alembic's 184th ANDA approval from the USFDA, comprising 160 final and 24 tentative approvals. Source: NSE India Archives