Aurobindo Pharma Ltd, a Hyderabad based engaging in manufacturing generic & API, has received tentative approval for escitalopram oxalate tablets 5mg, 10mg and 20mg from the US Food & Drug Administration (US FDA).
Escitalopram oxalate tablets 5mg, 10mg and 20mg are the generic equivalent of Forest Laboratories Inc's Lexpro tablets 5mg, 10mg and 20mg is an 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 US$ 2.6 billion for the twelve months ending September 2008 according to IMS.
The ANDA for escitalopram tablets is one of the first electronic applications and is approved in very short time.
Aurobindo now has 92 ANDA approvals (66 Final approvals and 26 tentative approvals) from US FDA.