Drug company Zydus Cadila announced on Thursday that Brexpiprazole tablets, used for the treatment of Schizophrenia, have received market approval from the US health regulator in the American market.
Tentual marketing approval for Brexpiprazol tablets of 0.25, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg was granted to the Company by the United States Food and Drug Administration (USFDA), the medicine company said in a statement.
Brexpiprazole is an atypical antipsychotic for the treatment of major depressive disorders (MDD) and schizophrenia, and is indicated as an adjunctive therapy with antidepressants.
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.