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( 27/12/2017 12:52)
Aurobindo Pharma gets USFDA nod for Fondaparinux Sodium injection

Aurobindo Pharma has received final approval from the 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 US$ 73 million for 12 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.

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