Aurobindo Pharma Limited announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Tranexamic Acid Injection, (100 mg/mL) 1000 mg/10 mL single-dose vial. This product is expected to be launched by the end of Fourth Quarter fiscal year 2015-2016. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Cyklokapron® Injection, 100 mg/mL, of Pharmacia and Upjohn Company.

Tranexamic Acid Injection is used in the treatment of short-term control of bleeding in hemophiliacs, including dental extraction procedures. This product is in the WHOs list of essential medicines. The approved product has an estimated market size of $50 million for the twelve months ending November 2015 according to IMS. This is the 22nd ANDA (including two tentative approval) approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products.

Aurobindo now has a total of 232 ANDA approvals (201 Final approvals including 10 from Aurolife Pharma LLC and 31 Tentative approvals) from USFDA.