 "Aurobindo Pharma gets USFDA nod for anti-infective injection")
Aurobindo Pharma has received approval from the US health regulator to make and market its anti-infective Linezolid injection in the American market.
"The company has received final approval from the United States Food & Drug Administration (USFDA) to manufacture and market Linezolid injection, 600 mg/300 mL (2 mg/mL)," Aurobindo said in a filing to BSE.
It is expected to be launched in the second quarter of the 2016-17 fiscal, and is the generic version of of Pharmacia & Upjohn Company's Zyvox injection in the same strength.
"The approved product has an estimated market size of $87 million for the twelve months ending June 2016 according to IMS," the company said.
This is the 36th abbreviated new drug application (ANDA) (including 2 tentative approvals) to be approved out of unit IV formulation facility in Hyderabad, it added.
"Aurobindo now has a total of 275 ANDA approvals (235 final approvals including 13 from Aurolife Pharma LLC and 40 tentative approvals) from USFDA, the company said.
The company's stock was trading 0.25 per cent up at Rs 772 on BSE in the afternoon.
