Aurobindo gets FDA nod for anti-depression drug

Aurobindo Pharma Ltd, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received tentative approval for escitalopram oxalate tablets in 5mg, 10mg and 20mg strengths from the US Food and Drug Administration (US FDA).

The abbreviated new drug application (ANDA) for escitalopram tablets, one of the first electronic applications to be approved, takes Aurobindo’s total ANDA approvals from the US FDA to 92 comprising 66 final and 26 tentative approvals, the company said in a filing to the BSE on Wednesday.

Escitalopram oxalate tablet 5mg, 10mg and 20mg, the generic equivalent of Forest Laboratories Inc’s Lexapro tablets, is used as an anti-depressant and falls under the central nervous system (CNS) segment. It is indicated for the treatment of depression associated with mood disorders and has a market size of about $2.6 billion for the 12 months ended September 2008, the release added.