Business
Hikma update on ANDA for generic Advair Diskus
Hikma update on ANDA for generic Advair Diskus.
About this update from Hikma Pharmaceuticals Plc
[{"type":"text","content":"\n \nRNS Number : 8287E Hikma Pharmaceuticals Plc 11 May 2017 \n\n \nHikma provides an update on the status of its ANDA for generic Advair Diskus®\n \nLondon, 11 May 2017 - 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, today announces that it has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) in relation to its abbreviated new drug application (ANDA) for its generic version of GlaxoSmithKline's Advair Diskus® (fluticasone propionate and salmeterol inhalation powder).\n \nThe FDA has categorised the CRL as 'Major'. Hikma is in the process of reviewing the response and will provide an update on its application as soon as practicable once it has completed its review of the CRL and discussed this with the FDA. Based on the initial assessment, no material issues were raised regarding the substitutability of the proposed device. \n \nGiven the nature of the feedback, Hikma believes there is a low likelihood of approval this year. Hikma is committed to bringing this important product to the US market and will work collaboratively with the FDA to address their outstanding questions. \n \nHikma's fluticasone propionate and salmeterol inhalation powder is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease and is delivered using Vectura's proprietary dry powder inhaler and formulation technology.\n \n-- ENDS --\n \n \nEnquiries\n \n\n\n\n\nInvestor Relations\n\n\n\n\n\n\n\nSusan Ringdal, VP Corporate Strategy and Investor Relations\n\n\n+44 (0)20 7399 2760/ +44 7776 477050\n\n\n\n\nLucinda Baker, Deputy Director of Investor Relations\n\n\n+44 (0)20 7399 2765/ +44 7818 060211\n\n\n\n\n\n\n\n\n\n\n\n\nMedia\n\n\n\n\n\n\n\nBrooke Clarke, VP Corporate Affairs\n\n\n+44 (0)20 7399 2795/ +44 7970 338 250\n\n\n\n\nBen Atwell/ Matthew Cole, FTI Consulting\n\n\n+44 (0)20 3727 1000\n\n\n\n\n \n \nAbout Hikma\nHikma Pharmaceuticals PLC is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded ...