Aurobindo Pharma has received approval from the US health regulator to market Polymyxin B for Injection, an anti-infective drug, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Polymyxin B for Injection USP, Aurobindo Pharma said in a regulatory filing.
“This product is expected to be launched in second quarter of FY16-17,” it added.
The company’s product is therapeutically equivalent to Eurohealth International Sarl’s Polymyxin B for Injection USP.
Polymyxin B for Injection is used in treating urinary tract infections, meninges, among others.
The approved product has an estimated market size of $7.6 million for the 12 months ended February 2016, according to IMS, the company said.
Aurobindo now has 252 Abbreviated New Drug Application (ANDA) approvals from the USFDA.
Shares of the company were trading up by 0.71 per cent at Rs 758.50 on the BSE.