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( 27/12/2017 12:03)
Aurobindo Pharma - Press Release / Media Release

Aurobindo Pharma receives USFDA Approval for Fondaparinux Sodium Injection

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 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 Arixtrar 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 the twelve months ending October 2017 according to IMS.

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