Hyderabad: Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Escitalopram Oxalate tablets in dosages of 5mg, 10mg and 20mg.
The product is ready for launch. The abbreviated new drug application (ANDA) was earlier tentatively approved, the Hyderabad-based pharma company said in a press release.
Escitalopram Oxalate tablets are the generic equivalent of Forest Laboratories Inc’s Lexapro tablets in similar dosages. It is an anti-depressant and falls under the Central Nervous System (CNS) segment.
The drug is indicated for the treatment of depression associated with mood disorders and has a market size of approximately $2.8 billion for the 12 months ended March 31, 2012 according to IMS.
The product has been approved out of Unit III formulations facility in Hyderabad. Aurobindo now has a total of 158 ANDA approvals (133 final approvals including one from Aurolife Pharma LLC and 25 tentative approvals) from USFDA, the release added.
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