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Hikma provides update on generic Advair Diskus®
Hikma provides update on generic Advair Diskus®.
About this update from Hikma Pharmaceuticals Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 9150L\n Hikma Pharmaceuticals Plc\n 15 January 2021\n \n \n \n \n This announcement contains inside information.\n \n \n \n \n \n \n London, 15\n \n \n January 2021\n \n \n - \n Hikma Pharmaceuticals PLC\n (Hikma), the multinational pharmaceutical company, annou\n nces that it has temporarily paused the launch of its generic version of GlaxoSmithKline's Advair Diskus®1. \n \n \n \n \n \n Following the US FDA's approval of Hikma's Abbreviated New Drug Application (ANDA) for generic Advair Diskus® in December 2020, Hikma has submitted to the US FDA an amendment to its application. The amendment reflects enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA application. This amendment will be classified as a Prior Approval Supplement and will not affect the approved status of Hikma's ANDA for generic Advair Diskus®.\n \n \n \n \n \n Hikma will work closely with the FDA in its review and will commence distribution of the product once the review has been completed. \n \n \n \n \n \n \n \n \n \n 1\n \n Advair® and Advair Diskus® are registered trademarks of GSK group of companies.\n \n \n \n \n - ENDS -\n \n The person responsible for the release of this announcement on behalf of Hikma is Peter Speirs (Company Secretary).\n \n \n \n \n Enquiries \n Hikma Pharmaceuticals PLC \n \n \n \n Susan Ringdal\n EVP, Strategic Planning and Global Affairs\n \n \n +44 (0)20 7399 2760/ +44 7776 477050\n [email protected]\n \n \n \n \n \n Steve Weiss\n David Belian\n US Communications and Public Affairs \n \n \n +1 732 720 2830/ +1 732 788 8279\n +1 732 720 2814/+1 848 254 4875\n [email protected]\n \n \n \n \n \n \n Teneo (Press):\n \n Charles Armitstead / Camilla Cunningham +44 (0)7703 330 269/ +44 (0)7464 982\n \n 426\n \n \n \n \n \n \n About Hikma\n \n (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P, BBB-/stable Fitch and Ba1/stable Moody's)\n \n \n Hikma helps put better health within reach every day for millions of people in more than 50 countries around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the ...