HERTFORDSHIRE, England and
PITTSBURGH, Nov. 9, 2017 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Clofarabine
Injection, 20 mg/20 mL (1 mg/mL) Single-Dose Vials, a generic
version of Genzyme's Clolar®. Mylan 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
the treatment of pediatric patients 1 to 21 years old with relapsed
or refractory acute lymphoblastic leukemia after at least two prior
regimens.
Mylan is one of the largest suppliers of cancer medicines by
volume in the U.S., with a robust oncology portfolio of more than
40 products.
Clofarabine Injection, 20 mg/20 mL (1 mg/mL) Single-Dose Vials
had U.S. sales of approximately $53
million for the 12 months ending September 30, 2017, according to IQVIA.
Currently, Mylan has 219 ANDAs pending FDA approval,
representing approximately $93.5
billion in annual brand sales. Forty-five of these pending
ANDAs are potential first-to-file opportunities, representing
$42.1 billion in annual brand sales,
for the 12 months ending August 31,
2017, according to IQVIA. Currently, one out of every 13
prescriptions filled in the U.S. – brand-name or generic – is a
Mylan product.
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.
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SOURCE Mylan N.V.