Zydus Cadila receives tentative approval from US FDA for Brexpiprazole tablets

Zydus Cadila has received tentative approval from the US Food and Drug Administration (FDA) to market Brexpiprazole tablets in the strength of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, the company notified via a statement.

The statement also said that Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of Major Depressive Disorder (MDD) and for treatment of schizophrenia. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.