London, 15 July 2015 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, today announces it has it has received approval from the U.S. Food and Drug Administration (“FDA”) for its supplemental Abbreviated New Drug Application (“sANDA”) for thiotepa for injection USP, 15mg/vial.
Thiotepa is indicated for the palliation of a wide variety of neoplastic diseases, with the most consistent results seen in tumors related to adenocarcinoma of the breast and ovary. It will be the second product previously marketed by Bedford Laboratories to be launched by Hikma in the United States. Thiotepa is currently on the FDA’s Drug Shortages list and Hikma has the only approved active US ANDA.
Said Darwazah, Chairman and CEO of Hikma said, “We are making good progress with the transfer of the Bedford products to our manufacturing facilities, leveraging our strong R&D, regulatory and manufacturing capabilities. Thiotepa is used in the treatment of a variety of cancers. It has been on shortage in the US for several years and we are very pleased to be able to provide a resolution to this critical situation."