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The US health regulator has given approval to Aurobindo Pharma, for manufacturing and marketing generic version of Fondaparinux Sodium injection, which is used to prevent deep vein thrombosis.
The company stated that, the approval is for multiple strengths of Fondaparinux Sodium injection of 2.5 mg/0.5 ml, 5 mg/0.4 ml, 7.5 mg/0.6 ml, and 10 mg/0.8 ml single-dose prefilled syringes and the product will be launched in Jan 2018.
Moreover, the approved product is a bio equivalent and therapeutically equivalent to the reference listed drug product Arixtra Injection of Mylan Ireland.
