Aurobindo Pharma announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fondaparinux Sodium injection, 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 approved ANDA is a bioequivalent and therapeutically equivalent to the reference listed drug (RLD) product Arixtra Injection of Mylan Ireland. The product will be launched in January 2018.

Fondaparinux Sodium injection is used to prevent deep vein thrombosis (DVT). The approved product has an estimated market size of USD 73 million for the twelve months ending October 2017 according to IMS.

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 & ophthalmic products. Aurobindo now has a total of 350 ANDA approvals (313 Final approvals including 17 from Aurolife Pharma LLC and 37 tentative approvals) from USFDA.

Shares of the company gained Rs 13.2, or 1.93%, to trade at Rs 697.15. The total volume of shares traded was 506,922 at the BSE (1.33 p.m., Wednesday).