Aurobindo gets FDA nod for antibiotic drug
City-based Aurobindo Pharma on Wednesday said it received final approval from the US health regulator to manufacture and market its generic antibiotic drug, Vancomycin Hydrochloride for Injection, in the American market.
Hyderabad: City-based Aurobindo Pharma on Wednesday said it received final approval from the US health regulator to manufacture and market its generic antibiotic drug, Vancomycin Hydrochloride for Injection, in the American market. The company expects to launch the product in the later part of the next fiscal.
"The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Vancomycin Hydrochloride for Injection USP, g/vial and 10 g/vial ( (Pharmacy Bulk Package)", the pharma firm said in a release.
The company's product is the generic version of US-based Fresenius Kabi's Vancomycin Hydrochloride for Injection USP, 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 $160 million for the twelve months ending January 2016, Aurobindo said, citing IMS data.
