Aurobindo Pharma receives US FDA's nod for tranexamic acid and paricalcitol

Aurobindo Pharma on January 16, 2016 announced that it has received final approval from the US Food & Drug Administration (USFDA) for manufacturing tranexamic acid injection (100 mg/mL) and paricalcitol capsules (1 mcg, 2 mcg, and 4 mcg).
 
Tranexamic acid injection is used in the treatment of short-term control of bleeding in hemophiliacs, including dental extraction procedures. Aurobindo Pharma expects to launch tranexamic acid injection, a generic version of Pharmacia and Upjohn Company’s Cyklokapron, by the end of Q4 FY15-16. This product is in the WHOs list of essential medicines. Tranexamic acid injection has an estimated market size of $ 50 million for the twelve months ending November 2015, according to IMS.
   
Paricalcitol capsule, a generic version of Abbvie’s Zemplar, is used for the prevention and treatment of high levels of parathyroid hormone in certain patients with chronic kidney disease. The approved product has an estimated market size of $ 38 million for the twelve months ending November 2015, according to IMS. Aurobindo Pharma will launch paricalcitol capsule in Q1 FY16-17.