Avenacy Launches Tranexamic Acid Injection, USP to the U.S.

Avenacy’s new Tranexamic Acid Injection, USP, indicated for use during and following tooth extraction, is now available in the United States.

The Schaumburg, Illinois-based specialty pharmaceutical company, which is focused on supplying critical injectable medications, announced Monday that it had launched Tranexamic Acid Injection, USP as a therapeutic generic equivalent for Cyklokapron® as approved by the U.S. Food and Drug Administration.The new product is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

“In less than one year since starting Avenacy, we have launched 10 essential injectable medications – a formidable achievement and testament to our commercial expertise in specialty pharmaceuticals,” Jeff Yordon, co-founder and CEO of Avenacy, says in a press release. “Since our company’s inception in October 2023, we have aimed to quickly deliver safe, effective, quality specialty injectables to hospitals and providers across the U.S., and the launch of Tranexamic Acid injection marks another important step in fulfilling this mission. The rest of 2024 is poised to be a transformative year for the business, as we remain focused on launching several additional products.”

Avenacy's Tranexamic Acid Injection, USP is available in 1,000 mg/10mL(100 mg per mL) 10-pack single-dose vials. In line with the company’s mission to champion patient safety and streamline patient care, it will feature Avenacy's highly differentiated packaging and labeling to support accurate medication selection.

Avenacy will begin shipping Tranexamic Acid Injection, USP to wholesale partners this week. The specialty pharmaceutical company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP-standards, Avenacy states.

Tranexamic Acid Injection, USP had U.S.sales of about $28 million for the 12 months ending in June 2023, according to IQVIA, the press release states.