New Delhi: Aurobindo Pharma said it has received final approval from the US health regulator to manufacture and market its generic version of Fondaparinux Sodium injection used to prevent deep vein thrombosis (DVT).
The approval by US Food & Drug Administration (USFDA) 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, the company said in a statement.
“The product will be launched in January 2018,” it added.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Arixtra Injection of Mylan Ireland, it said.
Citing IMS data, the company said the injection has an estimated market size of USD 73 million for the 12 months ended October 2017.
“This is the 52nd ANDA (including 2 tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable and ophthalmic products,” the company said.