Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Vancomycin Hydrochloride for Injection USP, 5 g/vial and 10 g/vial (Pharmacy Bulk Package). 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, 5 g/vial and 10 g/vial (Pharmacy Bulk Package), 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$ 160 million for the twelve months ending January 2016 according to IMS. This is the 28 th 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 247 ANDA approvals (212 Final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA.