New Delhi : Aurobindo Pharma has received final approval from the US health regulator to market its generic antibiotic drug Vancomycin Hydrochloride for Injection, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Vancomycin Hydrochloride for Injection USP (Pharmacy Bulk Package), Aurobindo Pharma said in a regulatory filing.
“This product is expected to be launched in the later part of FY16-17,” it added.
The company’s product is the generic version of US-based Fresenius Kabi’s Vancomycin Hydrochloride for Injection USP. It is an antibiotic used in the treatment of severe infections.
“The approved product has an estimated market size of USD 160 million for the twelve months ending January 2016 according to IMS,” the company said.
The Hyderabad-based firm now has a total of 247 Abbreviated New Drug Application (ANDA) approvals from the USFDA.
Shares of Aurobindo Pharma were trading 1.44 per cent up at Rs 746 apiece during afternoon session on the BSE.