Aurobindo Pharma has received final USFDA approval to manufacture and market Levofloxacin injection, an anti-infective used in the treatment of bacterial infection in adults in the US markets. The approval is for Levofloxacin in 5 per cent Dextrose injection in the strengths of 250 mg/50 ml, 500 mg/100 ml, and 750 mg/150 ml, single use containers and the product is expected to be launched in the first quarter of 2016-17.
The approved product is bio-equivalent and therapeutically equivalent to the reference listed drug product (RLD) Levaquin (Levaquin in 5 per cent Dextrose) by Janssen Pharmaceuticals, Inc. The product is estimated to have a market size of USD 46 million for the twelve months ending December 2015. Levaquinis is used to treat bacterial infections that cause bronchitis or pneumonia and to treat people who have been exposed to anthrax or plague.
Company Profile : Aurobindo Pharma Ltd
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