Ahmedabad-based pharmaceutical company 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 United States 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 company informed in a statement.
Brexpiprazole is an atypical antipsychotic which is indicated for use as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) and for the treatment of schizophrenia.
Zydus Cadila noted that it would manufacture the drug at its manufacturing facility at the SEZ, Ahmedabad.
The company 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.
(With PTI Inputs)