Hikma resumes launch of generic Advair Diskus®
Hikma Pharmaceuticals has resumed the launch of its generic Advair Diskus in the US after receiving FDA approval for an amendment to its Abbreviated New Drug Application. The amendment was necessary to enhance packaging controls in compliance with new industry standards. The generic product is available in 100mcg/50mcg and 250mcg/50mcg doses, aimed at improving access to this critical medication for patients and healthcare providers in the US.
- FDA approval received for enhanced packaging controls.
- Resumption of the launch improves availability of a critical medication.
- None.
LONDON, April 20, 2021 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that it has resumed the launch of its generic version of GlaxoSmithKline's Advair Diskus®1 in the US following US FDA approval of an amendment Hikma submitted to its Abbreviated New Drug Application in January 2021. The amendment reflected enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA.
Hikma will immediately resume launch activities of its generic product for Advair Diskus® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.
Siggi Olafsson, Chief Executive Officer of Hikma, said: "We appreciate the FDA's timely review and approval of our amendment and are now immediately resuming the launch of our high quality, substitutable generic version of Advair Diskus®. We are very pleased to improve availability of this critical medicine for patients and healthcare providers in the US."
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal EVP, Strategic Planning and Global Affairs | +44 (0)20 7399 2760/ +44 7776 477050
|
Steve Weiss David Belian US Communications and Public Affairs | +1 732 720 2830/ +1 732 788 8279 +1 732 720 2814/+1 848 254 4875 |
Teneo (Press):
Charles Armitstead / Claire Scicluna | +44 (0)7703 330 269/+44 (0)7835 395 028 |
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P, BBB-/stable Fitch and Ba1/stable Moody's)
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 UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com
1 Advair® and Advair Diskus® are registered trademarks of GSK group of companies.
View original content:http://www.prnewswire.com/news-releases/hikma-resumes-launch-of-generic-advair-diskus-301273105.html
SOURCE Hikma Pharmaceuticals USA Inc.
FAQ
What is the stock symbol for Hikma Pharmaceuticals?
When did Hikma Pharmaceuticals announce the resumption of its Advair Diskus launch?
What did Hikma Pharmaceuticals receive from the FDA regarding Advair Diskus?
What are the doses available for Hikma's generic Advair Diskus?
