From USFDA
Aurobindo Pharma announced that the Company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Vancomycin Hydrochloride for Injection USP, 500 mg/vial and 1 g/vial. This product is expected to be launched in the later part of FY16-17.The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Vancomycin Hydrochloride for Injection USP, 500 mg/vial and 1 g/vial, of Fresenius Kabi USA, LLC.
Vancomycin Hydrochloride for Injection is an antibiotic used in the treatment of severe infections caused by susceptible strains of methicillin-resistant (Beta-lactam resistant) staphylococci and others. The approved product has an estimated market size of US$ 94 million for the twelve months ending January 2016 according to IMS.
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