HERTFORDSHIRE, England and
PITTSBURGH, July 11, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL) today announced the U.S. launch of Temozolomide
Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, which is
a generic version of Merck's Temodar®. Mylan received final
approval from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) for this product.
Temozolomide Capsules are indicated for the treatment of adult
patients with newly diagnosed cancerous tumors known as
glioblastoma multiforme concomitantly with radiotherapy and then as
maintenance treatment.
Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and
250 mg, had U.S. sales of approximately $176.5 million for the 12 months ending
May 31, 2016, according to IMS
Health.
Currently, Mylan has 246 ANDAs pending FDA approval representing
$107.4 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.