Alembic Pharmaceuticals gets USFDA nod for generic antidepressant tablets

Alembic Pharmaceuticals Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of Brexpiprazole tablets used in treatment of major depressive disorder. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Brexpiprazole tablets of strengths 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, the company said in a statement.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti tablets of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, of Otsuka Pharmaceutical Company, Ltd, it added.

Brexpiprazole is an atypical antipsychotic used as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, and also used in treatment of schizophrenia in adults and pediatric patients aged 13 years and older.


Citing IQVIA data, Alembic said Brexpiprazole tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of USD 2 billion for 12 months ended September 2024.