Aurobindo's new generic wins FDA approval

Aurobindo Pharma receives FDA approval for Levofloxacin in Dextrose Injection

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The product is expected to be launched in Q1 FY16-17

Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Levofloxacin in 5 percent Dextrose Injection, 250 mg/50 mL (5 mg/mL), 500 mg/100 mL (5 mg/mL), and 750 mg/150 mL (5 mg/mL), single-use containers. The product is expected to be launched in Q1 FY16-17.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Levaquin (Levaquin in 5 percent Dextrose) by Janssen Pharmaceuticals.

Levofloxacin in Dextrose Injection is an Anti-Infective used in the treatment of bacterial infection in adults. The approved product has an estimated market size of $46 million for the twelve months ending December 2015 according to IMS.

 

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