Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Linezolid Injection, 600 mg/300 mL (2 mg/mL). The product is expected to be launched by Q2 FY2016-17. The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Zyvox Injection, 600 mg/300 mL (2 mg/mL), of Pharmacia & Upjohn Company (Pharmacia).
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, India 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 USFDA.
