Lupin gets US FDA nod for anti-bacterial tablet

PTI New Delhi | Updated on June 22, 2011

Drug firm Lupin today said its US subsidiary, Lupin Pharmaceuticals Inc, has received the US health regulator’s nod to market generic levofloxacin tablets, used for the treatment of bacterial infections, in the American market.

The United States Food and Drug Administration (USFDA) has granted final approval for the company’s abbreviated new drug application (ANDA) to market a generic version of levofloxacin tablets, Lupin Ltd said in a statement.

Levofloxacin is marketed under the brand name Levaquin by Ortho McNeil (Johnson & Johnson) in the US market.

“Levaquin tablets had annual sales of approximately $1.6 billion for the twelve months ended March, 2011, based on IMS Health sales data,” Lupin said.

The company’s levofloxacin tablets in the strengths of 250 mg, 500 mg and 750 mg are the generic equivalent of Levaquin tablets in the same strengths, it added.

Levofloxacin is used for treating a broad spectrum of bacterial infections.

Shares of Lupin Ltd were being quoted at Rs 433.60 apiece in morning trade on the Bombay Stock Exchange (BSE) today, down 0.32 per cent from their previous close.

Published on June 22, 2011

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