Aurobindo Pharma has received final approval from the USFDA to manufacture and market its Tranexamic acid injection, used for treating hemophilia, in the American market.
The company plans to launch the product by the end of this fiscal.
“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,” Aurobindo Pharma said in a statement.
The approved abbreviated new drug application (ANDA) is generic version of Pharmacia and Upjohn Company’s Cyklokapron injection in the strength of 100 mg/mL, it added.
“The approved product has an estimated market size of USD 50 million for the twelve months ending November 2015, according to IMS,” it said.
Tranexamic acid injection is used in the treatment of short-term control of bleeding in people suffering from hemophilia, including dental extraction procedures. This product is in the WHO list of essential medicines, it added.
Hemophilia is a group of hereditary genetic disorders that impairs the body’s ability to control blood clotting, which is used to stop bleeding when a blood vessel is broken.
Aurobindo Pharma currently has a total of 232 ANDA approvals (201 final approvals including 10 from Aurolife Pharma LLC and 31 tentative approvals) from USFDA.