LPI receives final FDA approval for generic version of Levaquin tablets

Lupin Pharmaceuticals, Inc. (LPI) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of Ortho McNeil's Levaquin® (levofloxacin) tablets.  Commercial shipment of the product has commenced.

Lupin's levofloxacin 250 mg, 500 mg and 750 mg tablets are the AB-rated generic equivalent of Levaquin, a synthetic broad spectrum antibacterial agent used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.   Levaquin tablets had annual sales of approximately $1.6 billion for the twelve months ended March 2011, based on IMS Health sales data.

Source:

Lupin Pharmaceuticals, Inc.

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