HERTFORDSHIRE, England and
PITTSBURGH, June 24, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Dutasteride
Capsules, 0.5 mg, the generic version of GlaxoSmithKline's
Avodart® Capsules. 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 as
monotherapy for the treatment of symptomatic benign prostatic
hyperplasia (BPH) in men with an enlarged prostate to improve
symptoms, reduce the risk of acute urinary retention and reduce the
risk of the need for BPH-related surgery. It may also be used with
tamsulosin for the treatment of symptomatic BPH in men with an
enlarged prostate.
Dutasteride Capsules, 0.5 mg, had U.S. sales of approximately
$297.2 million for the 12 months
ending April 30, 2016, according to
IMS Health.
Currently, Mylan has 248 ANDAs pending FDA approval representing
$107.6 billion in annual brand sales,
according to IMS Health. Forty-three of these pending ANDAs are
potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12
months ending December 31, 2015,
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 more than 1,400 generic and branded pharmaceuticals,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS in the developing world depend.
We market our products in approximately 165 countries and
territories. Our global R&D and manufacturing platform includes
more than 50 facilities, and 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.
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SOURCE Mylan N.V.