FDA determined that the ANDA is bioequivalent therefore, therapeutically equivalent to the reference listed drug, Cyklokapron – tranexamic acid injection solution.
The injection is indicated in hemophilia patients for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
Manufacturing of tranexamic acid injection will be carried out by Bioindustria in Italy.
Acella Pharmaceuticals vice president and head of Research and Development Allen Fields said, "The approval of Tranexamic Acid Injection continues to demonstrate our strategy to work with global partners to gain approvals of ANDA, NDAs, and 510Ks."
Acella chief operating officer Art Deas said developing and nurturing business and scientific partnerships that drive new product introductions is critical to the company’s success at Acella.
"We are pleased to support our prescribers and patients with therapeutically relevant and important products that offer a strong standard of excellent quality," Deas said.
The company develops, markets, sells and distributes a broad portfolio of non-branded pharmaceutical and other products in the areas of dermatology, women’s health, pediatrics and other applications.
Image: Acella’s tranexamic acid injection will be manufactured by Bioindustria in Italy. Photo: courtesy of Baitong333/ freedigitalphotos.net