Lupin gets FDA nod for anti-depression generic

Mumbai: Pharma major, Lupin, announced that its subsidiary Lupin Pharmaceuticals has received final approval for its Escitalopram tablets (Escitalopram oxalate) 5mg, 10mg, and 20mg, from the US FDA to market a generic version of Forest Laboratories' Lexapro Tablets, 5mg, 10mg, and 20mg.

Escitalopram Oxalate tablets 5mg, 10mg and 20mg are the generic equivalent of Forest Laboratories' Lexapro tablets 5mg, 10mg and 20mg, used as anti-depressant and falls under the Central Nervous System (CNS) segment. It is indicated for treatment of depression associated with mood disorders and has a market size of approximately $2.8 billion for the 12 months ending March 2012, according to IMS.

Furthermore, Lupin continues to remain the fifth largest generics player in the US (5.5 percent market share by prescriptions, IMS Health), the only Asian company to achieve that distinction. The US FDA had during the past week also given nod to Aurobindo Pharma to manufacture and market generic Escitalopram Oxalate.