Alembic Pharmaceuticals has received USFDA tentative approval for its ANDA Brexpiprazole Tablets
The US Food and Drug Administration (USFDA) has tentatively approved Alembic Pharmaceuticals’ Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. The approved ANDA is therapeutically equivalent to Otsuka Pharmaceutical Co., Limited’s Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg,