Aurobindo Pharma gets USFDA nod for Tranexamic Acid injection
Hyderabad-based Aurobindo Pharma Ltd. on Saturday announced that it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Tranexamic Acid injection, (100 mg/mL) 1000 mg/10 mL single-dose vial. Tranexamic Acid injection is used in the treatment of short-term control of bleeding in hemophiliacs, including dental extraction procedures, and this product is expected to be launched by the end of March 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,” Aurobindo Pharma said in a statement. The approved product has an estimated market size of $50 million annually and is in the WHO’s list of essential medicines. Aurobindo Pharma now has a total of 232 ANDA approvals (201 final approvals including 10 from Aurolife Pharma LLC and 31 tentative approvals) from USFDA. This is the 22nd ANDA approved out of Unit IV formulation facility in Hyderabad used for manufacturing general injectable products.
January 16, 2016 | 06:00pm IST
to success.