Aurobindo Pharma Gets US FDA Tentative Approval To Market ‘Escitalopram’

Aurobindo Pharma Gets US FDA Tentative Approval To Market ‘Escitalopram’The US Food and Drug Administration (USFDA) has given tentative approval to Aurobindo Pharma, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), to market Escitalopram Oxalate tablets in variable strengths.

Aurbindo will market the pills in dosages of 5mg, 10mg and 20mg.

Escitalopram oxalate, Lexapro by Forest Laboratories in US and elsewhere by Lundbeck as Cipralex, Sipralexa, Seroplex and also as Lexapro, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) group.

It is approved for treating major depressive disorder and generalized anxiety disorder. The other indications of the drug include social anxiety disorder, panic disorder and obsessive-compulsive disorder.

According to IMS release, Escitalopram Oxalate has a market size of around US $2.6 billion for the twelve months ending September 2008.

The abbreviated new drug application (ANDA) for escitalopram tabs, which is one of the first electronic applications to be approved, takes

Presently, Aurobindo has 92 ANDA approvals from the USFDA that includes 66 final approvals and 26 tentative approvals.

Aurobindo Pharma, on March 03, has signed up a series of agreements with Pfizer.

The contract comprises commercializing medicines, which are no longer patent protected, and have lost market uniqueness in US and Europe.

The deals are a development of a five-product U.S. deal Pfizer and Aurobindo signed during July Last year (2008).

At 02:50 p.m., the shares of the company gained 1.89% to trade at Rs 159 on the Bombay Stock Exchange (BSE). The share price has seen a 52-week high of Rs 360 and a low of Rs 101.60 on BSE.

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