Aurobindo Pharma 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 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 twelve months ending October 2017.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
