Hikma Pharmaceuticals Plc Hikma receives FDA approval for generic Vascepa(R) (7388N)
22 Maggio 2020 - 8:00AM
UK Regulatory
TIDMHIK
RNS Number : 7388N
Hikma Pharmaceuticals Plc
22 May 2020
London, May 22, 2020 - Hikma Pharmaceuticals PLC (Hikma), the
multinational generic pharmaceutical company, today announces that
its wholly owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has
received approval from the US Food and Drug Administration (FDA)
for its Icosapent Ethyl Capsules, 1 gm, the generic equivalent to
Vascepa(R)1 .
In March 2020, the United States District Court for the District
of Nevada invalidated six key Vascepa(R) patents owned by Amarin.
The District Court decision is currently being appealed.
Brian Hoffmann, President of Generics said, "The approval for
our generic version of Vascepa(R) is an important milestone towards
bringing this product to market. This approval demonstrates the
strength of our regulatory capabilities and our commitment to
provide patients and healthcare providers in the US with the
high-quality medicines they need."
(1) Vascepa(R) is a registered trademark of Amarin
Pharmaceuticals Ireland Limited.
- 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
u scommunications @hikma.com
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1/stable
Moody's and BB+/positive S&P)
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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