Lupin receives US FDA nod for Escitalopram Oxalate tablet

Lupin receives US FDA nod for Escitalopram Oxalate tablet
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First Published: Mon, Jun 16 2008. 02 06 PM IST
Updated: Mon, Jun 16 2008. 02 06 PM IST
PTI
Mumbai : Pharma company Lupin today said it has received US regulatory approval for Escitalopram Oxalate tablets, used in the treatment of depressive disorders.
The company has received tentative approval for the Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate tablets of 10 mg and 2 mg variants from the US Food and Drug Administration (US FDA), Lupin said in a filing to the Bombay Stock Exchange.
Escitalopram tablets are the generic equivalent of Lexapro tablets and are used in the treatment of major depressive disorder, it said.
The product would be introduced in the market through Lupin’s strong network of national wholesalers and drug stores post patent expiry in March 2012, the filing stated.
With the approval of the Escitalopram Oxalate tablets, the cumulative ANDA approvals stands at 30, with 33 pending approvals from the US FDA.
“We look forward to bringing Escitalopram Oxalate tablets as an affordable generic equivalent for the patients in the US, post patent expiry. The approval will strengthen our DTM generic product basket and will have a measurable impact on the US healthcare system,” Lupin Managing Director Kamal Sharma said.
Shares of Lupin were trading at Rs724.05, up 2.85% in the afternoon trade on the BSE.
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First Published: Mon, Jun 16 2008. 02 06 PM IST