Aurobindo Pharma gets USFDA nod for generic deep vein thrombosis drug

Aurobindo Pharma Limited said it received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fondaparinux Sodium injection — a bioequivalent and therapeutic equivalent to Arixtra of Mylan Ireland.

The product, used to prevent deep vein thrombosis (DVT), will be launched next month.

“The approved product has an estimated market size of US$ 73 million for the twelve months ending October 2017 according to IMS,” the company said.

This is the 52nd ANDA (or generic drug) approvals to be granted to the company’s Unit IV formulation facility in Hyderabad.

The plant is used for manufacturing general injectable & ophthalmic products.

Aurobindo now has a total of 350 ANDA approvals comprising 313 Final approvals — including 17 from Aurolife Pharma — and 37 tentative approvals from USFDA.