Zydus Cadila Gets USFDA Approval to Market Depression Drug in United States

Pharmaceutical company Zydus Cadila announced on Saturday that it had received approval from the U.S. health regulator to bring vortioxetine tablets, used to treat depression, to the U.S. market.

The company has received final approval from the United States Food and Drug Administration (USFDA) to market Vortioxetine tablets in 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 plant in the Ahmedabad SEZ, Zydus Cadila noted.

The group now has 322 approvals and has so far filed more than 400 Abbreviated New Drug Applications (ANDAs) since starting the filing process in fiscal year 2003-04, he added. .

(Only the title and image of this report may have been reworked by Business Standard staff; the rest of the content is automatically generated from a syndicated feed.)

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