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FDA approves generic drug for hemophilia


 

vials and a syringe
Drug vials and a syringe

The US Food and Drug Administration (FDA) has approved a generic version of tranexamic acid for short-term control of bleeding in patients with hemophilia.

The drug, tranexamic acid injection (100 mg/mL) 1000 mg/10 mL single-dose vial, is a product of Aurobindo Pharma Limited.

The drug has been deemed bioequivalent and therapeutically equivalent to Cyklokapron® injection, 100 mg/mL, a product of Pharmacia and Upjohn Company.

Aurobindo Pharma Limited said the generic drug should be launched in the US by the end of March.

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