Aurobindo Pharma gets USFDA nod for Fondaparinux Sodium injection
Reported by: Shikha Jain
Aurobindo Pharma has recently received final approval from US Food & Drug Administration
(USFDA) to manufacture and market its generic version of Fondaparinux Sodium injection. The
product is approved in multiple strengths including 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6
mL, and 10mg/0.8mL single-dose prefilled syringes.
The product is approved based on its bioequivalence and therapeutic equivalence to the reference
listed drug product Arixtra Injection, a registered trademark of Mylan Ireland.
The product is indicated for prevention and treatment of deep vein thrombosis. It is the 52nd approved ANDA (including 2 tentative approvals) from Unit IV formulation facility based at Hyderabad, India for manufacturing general injectable and ophthalmic products. To date the company has a total of 350 ANDA approvals (313 final approvals, including 17 from Aurolife Pharma LLC, and 37 tentative approvals) from USFDA. The approved product has an estimated market size of USD 73 million for the 12 months ended October 2017.
The product is expected to be launched by late January 2018 or early February.
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