Business
Regulatory Approval Colchicine
Regulatory Approval Colchicine.
About this update from Hikma Pharmaceuticals Plc
[{"type":"text","content":"\n \nRNS Number : 0840T Hikma Pharmaceuticals Plc 30 September 2014 \n \n\n \n \n \nPRESS RELEASE \n \n \nHikma receives approval for colchicine 0.6mg capsules\nLondon, 30 September 2014 - Hikma Pharmaceuticals PLC (\"Hikma\") (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, today announces the approval of its New Drug Application (NDA) for colchicine 0.6mg capsules by the US Food and Drug Administration (FDA). Hikma will market its colchicine under the brand name MITIGARE™.\nMITIGARE™ is indicated for prophylaxis of gout flares in adults. This NDA has been approved under Section 505(b)(2) of the US Federal Food Drug and Cosmetic Act.\nSaid 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 product portfolio for the US market.\" \nAccording to IMS Health, sales of colchicine in the US market were approximately $688 million for the 12 months ending August 2014. \n----- ENDS -----\n \n \nEnquiries\nHikma Pharmaceuticals PLC\nSusan Ringdal, VP Corporate Strategy and Director of Investor Relations +44 (0)20 7399 2760/\n+44 7776 477050\nLucinda Henderson, Deputy Director of Investor Relations +44 (0)20 7399 2765/\n+44 7818 060211\n \nFTI Consulting &...