Zydus gets tentative USFDA nod to market schizophrenia drug

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DTMT Network

Zydus Cadila, Ahmedabad based global pharma company, has received a tentative USFDA approval to market Brexpiprazole tablets in the strength of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, the drug firm stated on September 9, 2021, in a press release.

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.

Zydus said that 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,” the drug firm said.


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