Aurobindo Pharma receives USFDA approval for Levofloxacin in Dextrose Injection
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.
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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.
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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.