Drug firm Zydus Cadila on Saturday said it has received approval from the US health regulator to market Vortioxetine Tablets, used to treat depression, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to market Vortioxetine tablets in the strengths of 5 mg, 10 mg, 20 mg, Zydus Cadila said in a statement.
Vortioxetine is used to treat depression. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain.
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, Zydus Cadila noted.
The group now has 322 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since it commenced the filing process in FY 2003-04, it added.