Aurobindo Pharma receives US FDA nod for anti-infective drug

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (FDA) to manufacture and market ant-infective drug linezolid injection, 600 mg/300 mL (2 mg/mL). The company expects to launch the product, a generic version of Pharmacia & Upjohn Company’s Zyvox injection, by Q2 FY2016-17.

Linezolid injection is an anti-infective used to treat infections caused by susceptible gram-positive bacteria in some specific conditions. The approved product has an estimated market size of $ 87 million for the twelve months ending June 2016, according to IMS.

This is the 36th ANDA (including 2 tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad used for manufacturing general injectable products. Aurobindo now has a total of 275 ANDA approvals (235 Final approvals including 13 from Aurolife Pharma LLC and 40 tentative approvals) from US FDA.