Zydus Cadila gets FDA’s final approval for Vortioxetine Tablets
Zydus Cadila has secured final approval from the US Food and Drug Administration (FDA) to market Vortioxetine Tablets in the strengths of 5mg, 10mg, 20mg for the treatment of depression.
The reference listed drug (RLD) of Vortioxetine Tablets is Trintellix Tablets in the US.
Vortioxetine is a selective serotonin reuptake inhibitor (SSRI) and serotonin receptor modulator that helps in restoring the balance of a certain natural substance (serotonin) in the brain.
Zydus Cadila said that it will manufacture Vortioxetine Tablets at its formulation manufacturing facility at the SEZ, Ahmedabad.
The Indian pharma manufacturer now has 322 approvals and has to date, filed more than 400 ANDAs since the start of the filing process in FY 2003-04.