Hikma Pharmaceuticals Plc Hikma provides update on generic Advair Diskus(R) (9150L)
2021年1月16日 - 12:59AM
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RNS Number : 9150L
Hikma Pharmaceuticals Plc
15 January 2021
This announcement contains inside information.
London, 15 January 2021 - Hikma Pharmaceuticals PLC (Hikma), the
multinational pharmaceutical company, annou nces that it has
temporarily paused the launch of its generic version of
GlaxoSmithKline's Advair Diskus(R)1 .
Following the US FDA's approval of Hikma's Abbreviated New Drug
Application (ANDA) for generic Advair Diskus(R) 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(R) .
Hikma will work closely with the FDA in its review and will
commence distribution of the product once the review has been
completed.
(1) Advair(R) and Advair Diskus(R) are registered trademarks of
GSK group of companies.
- ENDS -
The person responsible for the release of this announcement on
behalf of Hikma is Peter Speirs (Company Secretary).
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 / Camilla Cunningham +44 (0)7703 330 269/ +44
(0)7464 982 426
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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