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09/16/2021

FDA gives tentative nod to generic Rexulti from Zydus Cadila

Brexpiprazole is an atypical antipsychotic indicated for use as adjunctive therapy to antidepressants for the treatment of major depressive disorder and schizophrenia.
Sandra Levy
Senior Editor
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Zydus Cadila has received a tentative nod from the Food and Drug Administration for brexpiprazole tablets in dosage strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.

The product is the generic of Rexulti tablets.

[Read more: FDA gives tentative nod to Zydus Cadila's generic Truvada]

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

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

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