POTTERS BAR, England and
PITTSBURGH, March 11, 2015 /PRNewswire/ -- Mylan N.V.
(NASDAQ: MYL) and Mylan Inc. today announced the U.S. launch of
Buprenorphine Hydrochloride Sublingual Tablets, 2 mg and 8 mg,
which is the generic version of Reckitt Benckiser's
Subutex® Sublingual Tablets. 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 opioid dependence and is preferred
for induction.
Buprenorphine Hydrochloride Sublingual Tablets, 2mg and 8mg had
U.S. sales of approximately $107.8
million for the 12 months ending December 31, 2014, according to IMS Health.
Currently, Mylan has 281 ANDAs pending FDA approval representing
$104.6 billion in annual brand sales,
according to IMS Health. Forty-four of these pending ANDAs are
potential first-to-file opportunities, representing $27.3 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.
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SOURCE Mylan N.V.