HERTFORDSHIRE, England and
PITTSBURGH, Jan. 5, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ,
TASE: MYL) today announced the U.S. launch of Norgestimate and
Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg,
and 0.25 mg/0.025 mg, which is the generic version of Janssen's
Ortho Tri-Cyclen Lo® 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 prevention of pregnancy.(1)
Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025
mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, had U.S. sales of
approximately $488.6 million for the
12 months ending Sept. 30, 2015,
according to IMS Health. This product represents Mylan's 14th oral
contraceptive launch in the U.S.
Currently, Mylan has 270 ANDAs pending FDA approval representing
$101.5 billion in annual brand sales,
according to IMS Health. Fifty of these pending ANDAs are potential
first-to-file opportunities, representing $35.6 billion in annual brand sales, for the 12
months ending June 30, 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 nearly 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
30,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at mylan.com.
(1) Cigarette smoking increases the risk of serious
cardiovascular side effects from oral contraceptive use and this
risk increases with age. Women who use oral contraceptives should
be advised to not smoke. Consult your physician prior to beginning
oral contraceptive use.
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SOURCE Mylan N.V.