Aurobindo Pharma receives final approval for Escitalopram Oxalate Tablets

12 Sep 2012 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Escitalopram Oxalate Tablets 5mg, 10mg and 20mg (ANDA 090432), which was earlier tentatively approved. The product is ready for launch and has been approved out of Unit III formulations facility in Hyderabad, India

Escitalopram Oxalate Tablets 5mg, 10mg and 20mg are the generic equivalent of Forest Laboratories Inc’s Lexapro Tablets 5mg, 10mg and 20mg is an anti-depressant and falls under the Central Nervous Sytem (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 twelve months ending March 2012 according to IMS.

Aurobindo now has a total of 158 ANDA approvals (133 Final approvals including 1 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.

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