Aurobindo gets USFDA nod for generic anti-infective drug; shares up slightly

(Getty Images)
The company's shares were in the green despite a nearly 2% slump in the domestic equity markets.

Drug firm 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 the second quarter of FY16-17," it added.

The company's shares were trading in the green despite a major slump in the domestic equity markets. The benchmark BSE Sensex slumped 400 points after a 25 bps rate cut failed to meet market expectations. Most experts were expecting a 50 bps rate cut in the policy review meet.

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 twelve months ending February 2016, according to IMS, the company said.

Aurobindo now has a total of 252 Abbreviated New Drug Application (ANDA) approvals from the USFDA.