HERTFORDSHIRE, England and
PITTSBURGH, Aug. 13, 2018 /PRNewswire/ -- Global
pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced the
U.S. launch of Tadalafil Tablets USP, 20 mg, the first generic
version of the reference listed drug, Eli Lilly and Company's
Adcirca®. Mylan Pharmaceuticals received final
approval from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) and was awarded 180 days of
marketing exclusivity for this product, which is indicated for the
treatment of pulmonary arterial hypertension to improve exercise
ability.
"Mylan has a strong history of leading the way in creating
important access to generic medicines, and we're excited to
continue that tradition by offering the first generic to
Adcirca® Tablets," said Mylan CEO Heather Bresch. "Mylan offers more than 650
products in the U.S., and the addition of Tadalafil Tablets
strengthens our cardiovascular portfolio and commitment to these
patients."
U.S. sales for Tadalafil Tablets USP, 20 mg, were approximately
$510 million for the 12 months ending
May 31, 2018, according to IQVIA.
Currently, Mylan has 192 ANDAs pending FDA approval representing
approximately $88.3 billion in annual
brand sales, according to IQVIA. Forty-four of these pending ANDAs
are potential first-to-file opportunities, representing
$44.9 billion in annual brand sales,
for the 12 months ending December 31,
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 approximately 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.