HERTFORDSHIRE, England and
PITTSBURGH, Feb. 22, 2019 /PRNewswire/ -- Global
pharmaceutical company Mylan N.V. (NASDAQ: MYL) today
announced the U.S. launch of Buprenorphine and Naloxone Sublingual
Film, 8 mg/2 mg and 12 mg/3 mg, a generic version of Indivior's
Suboxone® Sublingual Film. Mylan Pharmaceuticals 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 opioid dependence and should be used
as part of a complete treatment plan to include counseling and
psychosocial support.
Prescription of this product is limited to healthcare providers
who meet certain qualifying requirements including notification to
Department of Health and Human services of their intent to
prescribe this product.
U.S. sales for Buprenorphine and Naloxone Sublingual Film, 8
mg/2 mg and 12 mg/3 mg, were approximately $1.87 billion for the 12 months ending
December 31, 2018, according to
IQVIA.
Currently, Mylan has 173 ANDAs pending FDA approval representing
approximately $85.8 billion in annual
brand sales, according to IQVIA. Forty-six of these pending ANDAs
are potential first-to-file opportunities, representing
$53.6 billion in annual brand sales,
for the 12 months ending June 30,
2018, 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.