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 Cyanocobalamin Injection USP, 1000 mcg/mL in 1mL, 10mL and 30 mL vials has been approved by the U.S. Food and Drug Administration (“FDA”).
8 January 2016
Cyanocobalamin Injection is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with certain conditions, including Addisonian (pernicious) anemia, gastrointestinal pathology, dysfunction, or surgery, small bowel bacteria overgrowth and folic acid deficiency. According to IMS Health, sales of Cyanocobalamin Injection in the US market were approximately $80 million for the 12 months ending November 2015.
Said Darwazah, Chairman and CEO of Hikma, said, “This approval demonstrates our strong regulatory capabilities and the successful execution of our strategy to develop a more differentiated injectable product portfolio."