Lupin Ltd announced that its subsidiary in the US, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for the abbreviated new drug application (ANDA) for escitaloprarn oxalate tablets 10 mg and 20 mg from the US Food and Drug Administration (US FDA).

Lupin's escitalopram tablets are the AB-rated generic equivalent of Lexapro tablets, indicated for the treatment of major depressive disorder. According to IMS Health sales data, the brand product had annual sales of approximately S2.6 billion for the twelve months ended March 200.

Commenting on the approval, Dr Kanal Sharma, managing director, Lupin Ltd said, "We are pleased to receive this approval and look forward to bringing escitalopram oxalate tablets as an affordable generic equivalent for the patients in the US, post patent expiry. We believe, it will strengthen our DTM generics product basket and will have a measurable impact on the US healthcare system".

According to a company press release, the product will be introduced in the market through LPI's strong network of national wholesalers and drug stores post patent expiry in March 2012. This will strengthen Lupin's presence in the SSRI (Selective Serotonin Reuptake Inhibitor) segment.

With the approval of escitalopram oxalate tablets, the cumulative ANDA approvals stand at 30 (including 3 tentative approvals) with 33 pending approvals from the US FDA.