Zydus Cadila said it received approval from the US Food & Drug Administration to sell new generation anti-depressant Vortioxetine in the US market.
The drug was first approved around seven years ago, and was developed by Denmark-based pharmaceuticals maker Lundbeck in the late 2000s.
Around 2007, Japanese pharmaceuticals maker Takeda agreed to pay an upfront sum of Lundbeck $40 million and up to $345 million in milestone payments under a marketing deal for the US and Japanese markets. Takeda also funded most of the development costs since then.
The exact status of the drug at present, as far as patent protection is concerned, is not clear.
For its part, Zydus said it will manufacture the drug at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.
With this, said the company, the group now has 322 approvals out of the 400 generic approvals filed for in the US since 2003-04.
Zydus’ Vortioxetine Tablets will be sold in strengths of 5 mg, 10 mg and 20 mg.
The drug works by increasing serotonin in the brain by preventing the elimination and reuptake of seratonin in the brain, and is classified as a selective serotonin reuptake inhibitor and serotonin receptor modulator.
Vortioxetine is an agonist of the serotonin 5-HT1A receptor, partial agonist of the 5-HT1B receptor, and antagonist of the serotonin 5-HT1D, 5-HT3, and 5-HT7 receptors, as well as an apparent ligand of the β1-adrenergic receptor.