HERTFORDSHIRE, England,
PITTSBURGH and DURBAN, South Africa,
Dec. 4, 2017
/PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) and its partner, Aspen (JSE: APN), today announced the U.S.
launch of Myleran (busulfan) Injection, 60 mg/10 mL (6 mg/mL)
Single-dose Vial, a generic version of Otsuka Pharmaceutical's
Busulfex® Injection. Aspen
received final approval from the U.S. Food and Drug Administration
(FDA) for its Abbreviated New Drug Application (ANDA) for this
product, which is indicated for use in combination with
cyclophosphamide as a conditioning regimen prior to allogeneic
hematopoietic progenitor cell transplantation for chronic
myelogenous leukemia. (1)
As part of its partnership with Aspen, Mylan will commercialize Busulfan
Injection, 60 mg/10 mL (6 mg/mL) Single-dose Vial in the
U.S. Mylan has one of the largest
injectable portfolios in the industry and is also one of the
largest suppliers of cancer medicines by volume in the
U.S.
U.S. sales for Busulfan Injection, 60 mg/10 mL (6 mg/mL)
Single-dose Vial were approximately $97
million for the 12 months ending Sept. 30, 2017, according to IQVIA.
About Mylan
Mylan is a global pharmaceutical company committed to
setting new standards in healthcare. Working together around the
world to provide 7 billion people access to high quality medicine,
we innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We offer a growing
portfolio of more than 7,500 marketed products around the world,
including antiretroviral therapies on which more than 40% of people
being treated for HIV/AIDS globally depend. We market our products
in more than 165 countries and territories. We are one of the
world's largest producers of active pharmaceutical ingredients.
Every member of our more than 35,000-strong workforce is dedicated
to creating better health for a better world, one person at a time.
Learn more at Mylan.com. We routinely post information that may be
important to investors on our website at
investor.mylan.com.
About Aspen
Aspen is a leading global
player in specialty, branded and generic pharmaceuticals with an
extensive basket of products that provide treatment for a broad
spectrum of acute and chronic conditions experienced through all
stages of life.
With a presence of nearly two decades in the
pharmaceutical sector, Aspen is
committed to sustaining life and promoting healthcare through
increasing access to high quality, affordable medicines and
products, with its core focus being in the Thrombosis, Anaesthetic,
High Potency & Cytotoxic and Nutritional therapeutic
categories.
Aspen has a strong
presence in both emerging and developed countries. Its emerging
market footprint includes SubSaharan Africa, Latin America, China, South East
Asia, Eastern Europe and
the Commonwealth of Independent States, comprising Russia and the former Soviet Republics.
It is also a leading pharmaceutical company in
developed countries including Australia and most notably, countries
throughout Western
Europe.
Aspen operates with an
established business presence in approximately 50 countries
spanning 6 continents and employs more than 10,000 people. The
Group operates 25 manufacturing facilities across 18 sites.
Aspen holds international
manufacturing approvals from some of the most stringent global
regulatory agencies including the FDA, TGA and EMA.
Aspen's manufacturing
capabilities are scalable to demand and cover a wide variety of
product types including oral solid dose, liquids, semi-solids,
steriles, biologicals, APIs and infant nutritionals.
With a market capitalisation of approximately $10 billion, Aspen is the largest pharmaceutical company
listed on the JSE Limited (share code: APN) and ranks amongst the
top 20 listed companies on this exchange. For more information
visit: http://www.aspenpharma.com/
(1) Generic Busulfex® for Injection causes severe and
prolonged myelosuppression. Hematopoietic progenitor cell
transplantation is required to prevent potentially fatal
complications of the prolonged myelosuppression.
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SOURCE Mylan N.V.