Zydus Cadila gets US FDA approval for antidepressant tablets

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

Zydus Cadila has received tentative approval from the US FDA to market Brexpiprazole tablets in the strength of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. (US RLD: Rexulti Tablets).

Brexpiprazole is an atypical antipsychotic indicated for use as adjunctive therapy to antidepressants for the treatment of Major Depressive Disorder (MDD) and treatment of schizophrenia.

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 321 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.