Zydus Cadila has stated that it has received approval from the United States Food & Drug Administration to sell the next generation antidepressant Vortioxetine in the United States market.
The drug was first approved around seven years ago and was developed by Danish pharmaceutical manufacturer Lundbeck in the late 2000s.
Around 2007, Japanese pharmaceutical maker Takeda agreed to pay Lundbeck an initial $ 40 million and up to $ 345 million in milestone payments as part of a commercialization deal for US markets. and Japanese. Takeda has also funded most of the development costs since then.
The exact status of the drug at present, with respect to patent protection, is unclear.
For his part, Zydus said he would manufacture the drug at the group’s formulation manufacturing plant in the Ahmedabad SEZ.
With that, the company said, the group now has 322 approvals out of the 400 generic approvals filed in the United States 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 serotonin 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, a partial agonist of the 5-HT1B receptor, and an antagonist of the serotonin 5-HT1D, 5-HT3 and 5-HT7 receptors, as well as an apparent ligand of 1 – adrenergic receptor.