Product, Press Release

Hikma receives FDA approval for Azathioprine Sodium Injection

London, 8 January 2016 – Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its supplemental Abbreviated New Drug Application (“sANDA”) for Azathioprine Sodium Injection USP, 100mg/vial has been approved by the U.S. Food and Drug Administration (“FDA”).

Azathioprine Sodium Injection is indicated as an adjunct for the prevention of rejection in renal homotransplantations. Azathioprine Sodium Injection is a niche product and Hikma will be the first to re-introduce this product to the market.  

Said Darwazah, Chairman and CEO of Hikma, said, “We are making good progress with the transfer of the Bedford products to our manufacturing facilitates, leveraging our strong R&D, regulatory and manufacturing capabilities. We are very pleased that azathioprine has been approved for the US market, and remain committed to prioritising the re-introduction of Bedford products for patients in need.”