Aurobindo Pharma Limited announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levofloxacin in 5% 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 % Dextrose) by Janssen Pharmaceuticals, Inc.
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 US$ 46 million for the twelve months ending December 2015 according to IMS.
This is the 25th ANDA (including two tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products. Aurobindo now has a total of 240 ANDA approvals (206 Final approvals including 10 from Aurolife Pharma LLC and 34 Tentative approvals) from USFDA.
