Aurobindo Pharma Ltd 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.
According to a company release, 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 $73 million for the 12 months ended October 31, 2017, according to IMS.
This is the 52nd ANDA (including 2 tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, used for manufacturing general injectable and ophthalmic products. Aurobindo now has 350 ANDA approvals (313 final approvals including 17 from Aurolife Pharma LLC and 37 tentative approvals) from USFDA.
The company shares were trading up by 1.78 per cent at Rs 696.15 on the BSE.