POTTERS BAR, England and PITTSBURGH, March 11,
2015 /PRNewswire/ -- Mylan N.V. (Nasdaq: MYL) and Mylan
Inc. today announced the U.S. launch of its Fentanyl Transdermal
System 37.5, 62.5 and 87.5 mcg/hr, adding to its existing offering
of Fentanyl Transdermal System 12, 25, 50, 75 and 100 mcg/hr. Mylan
currently is the only manufacturer that offers eight Fentanyl
Transdermal System dosage strengths, including three new strengths
– the first and only available "intermediate" dosages.
Mylan CEO Heather Bresch
commented: "Mylan's launch of Fentanyl Transdermal System 37.5,
62.5 and 87.5 mcg/hr, is an example of our commitment to innovate
to satisfy unmet needs. Mylan's Fentanyl Transdermal System is the
number one dispensed fentanyl transdermal system in the
U.S.i, and now, for the first time, patients have access
to additional dosing options through Mylan's launch of three new
strengths."
Mylan received final approval from the U.S. Food and Drug
Administration (FDA) for its Supplemental Abbreviated New Drug
Application (ANDA) for its Fentanyl Transdermal System 37.5, 62.5
and 87.5 mcg/hr.
Fentanyl Transdermal System's existing strengths, including the
12, 25, 50, 75 and 100 mcg/hr presentations, had U.S. sales of
approximately $767 million for the 12
months ending September 30, 2014,
according to IMS Health.
Currently, Mylan has 282 ANDAs pending FDA approval representing
$104.6 billion in annual brand sales,
according to IMS Health. Forty-three of these pending ANDAs are
potential first-to-file opportunities, representing $27.2 billion in annual brand sales, for the 12
months ending June 30, 2014,
according to IMS Health.
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 around 1,400 generic pharmaceuticals and several brand
medications. In addition, we offer a wide range of antiretroviral
therapies, upon which approximately 40% of HIV/AIDS patients in
developing countries depend. We also operate one of the largest
active pharmaceutical ingredient manufacturers and currently market
products in about 145 countries and territories. Our workforce of
approximately 30,000 people is dedicated to creating better health
for a better world, one person at a time. Learn more at
mylan.com.
i
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IMS Health, NPA™,
Dispensed Moving Annual Total (MAT) Prescriptions, December 2013
through November 2014.
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SOURCE Mylan N.V.