Hikma Pharmaceuticals Plc Hikma resumes launch of generic Advair Diskus(R) (0951W)
21 Aprile 2021 - 8:00AM
UK Regulatory
TIDMHIK
RNS Number : 0951W
Hikma Pharmaceuticals Plc
21 April 2021
London, 20 April 2021 - Hikma Pharmaceuticals PLC (Hikma), the
multinational pharmaceutical company, annou nces that it has
resumed the launch of its generic version of GlaxoSmithKline's
Advair Diskus(R)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(R) (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(R) . We are very
pleased to improve availability of this critical medicine for
patients and healthcare providers in the US."
(1) Advair(R) and Advair Diskus(R) are registered trademarks of
GSK group of companies.
- ENDS -
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal +44 (0)20 7399 2760/ +44 7776
EVP, Strategic Planning and Global Affairs 477050
uk-investors@hikma.uk.com
Steve Weiss +1 732 720 2830/ +1 732 788
David Belian 8279
US Communications and Public Affairs +1 732 720 2814/+1 848 254 4875
uscommunications@hikma.com
Teneo (Press):
Charles Armitstead / Claire Scicluna +44 (0)7703 330269/ +44
(0)7385 395028
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
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END
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