5 April 2016
Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Polymyxin B for Injection USP, 500,000 units/vial. This product is expected to be launched in Q2 FY16-17.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Polymyxin® B for Injection USP, 500,000 units/vial of Eurohealth International Sarl. Polymyxin B for Injection is an Anti-Infective used in the treatment of infections of the urinary tract, meninges, bloodstream and eye caused by susceptible strains of Pseudomonas aeruginosa. The approved product has an estimated market size of US$ 7.6 million for the twelve months ending February 2016 according to IMS.
This is the 31st ANDA (including two 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 252 ANDA approvals (216 Final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA.