NEW DELHI: Drug firm Zydus Cadila on Thursday said it has received approval from the US health regulator to market Brexpiprazole tablets, used for the treatment of schizophrenia, in the American market.
The company has received tentative approval from the US Food and Drug Administration (USFDA) 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 said in a statement.
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.
Zydus Cadila noted that it would manufacture the drug at its manufacturing facility at the SEZ, Ahmedabad.
The Ahmedabad-based group now has 321 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.