Aurobindo gets US FDA nod for anti-infective injection

Aurobindo Pharma Limited has received final approval from the US Food and Drug Administration(USFDA) to manufacture and market Levofloxacin in 5 per cent Dextrose injection.

The drug is expected to be launched in the first quarter of the next financial year.

The product is an anti-infective used in the treatment of bacterial infection in adults, according to the company.

Levofloxacin in 5 per cent Dextrose Injection has an estimated market size of $46 million for the 12 months ending December 2015, according to the IMS data.

The approved abbreviated new drug application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product Levaquin of Janssen Pharmaceuticals, Inc.



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