Aurobindo Pharma Ltd., a pharmaceutical company based in New Dehli, India, has received final approval from the US Food and Drug Administration (FDA) to manufacture and market a generic, injectable version of tranexamic acid (TA). Pfizer Injectables, a division of Pfizer, Inc., currently manufactures an injectable TA under the brand name Cyclokapron®. There is also an oral form of the drug.
TA, which belongs to a class of drugs known as antifibrinolytics, is a synthetic derivative of an essential amino acid protein called lysine. The drug, functioning primarily as a stopgap therapy by slowing the breakdown of blood clots, is indicated in patients with hemophilia for short-term use to reduce or prevent bleeding. First approved by the FDA in 1986, TA often allows providers to forgo the need for factor replacement therapy during and following tooth extraction.
The company plans to launch the drug by the end of 2016.
Source: firstwordpharma.com, January 17, 2016
