HERTFORDSHIRE, England and
PITTSBURGH, Dec. 28, 2016 /PRNewswire/ -- Mylan N.V.
(NASDAQ, TASE: MYL), today announced the U.S. launch of Ethynodiol
Diacetate and Ethinyl Estradiol Tablets USP, 1 mg / 0.05 mg.
Mylan's product was determined to be bioequivalent and, therefore,
therapeutically equivalent to the reference listed drug, Zovia®
1/50E-28 Tablets (Watson). Mylan's
subsidiary, Jai Pharma Limited, 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
use by women to prevent pregnancy. (1)
Currently, Mylan has more than 240 ANDAs pending FDA approval
representing approximately $95.6
billion in annual brand sales, according to IMS Health.
Forty-one of these pending ANDAs are potential first-to-file
opportunities, representing $32.5
billion in annual brand sales, for the 12 months ending
June 30, 2016, 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 2,700 generic and branded pharmaceuticals,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS worldwide depend. We market our
products in more than 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.
(1) Cigarette smoking increases the risk of serious
adverse effects on the heart and blood vessels from oral
contraceptive use. The risk increases with age and with heavy
smoking (15 or more cigarettes per day) and is quite marked in
women over 35 years of age. Women who use oral contraceptives are
strongly advised not to smoke.
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SOURCE Mylan N.V.