POTTERS BAR, England and
PITTSBURGH, May 5, 2015 /PRNewswire/ -- Mylan N.V. (NASDAQ:
MYL) today announced the U.S. launch of Levonorgestrel and Ethinyl
Estradiol Tablets USP, 0.15 mg/0.03 mg, which is the generic
version of Teva's Seasonale® Tablets. Mylan's partner
Famy Care Ltd. 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 in women who elect to use oral contraceptives as a method
of contraception.(1) Mylan's immediate shipment of Levonorgestrel
and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg represents the
company's tenth oral contraceptive product launch in the U.S.
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03
mg had U.S. sales of approximately $57.3
million for the 12 months ending December 31, 2014, according to IMS Health.
Currently, Mylan has 273 ANDAs pending FDA approval representing
$106.9 billion in annual sales,
according to IMS Health. Forty-seven of these pending ANDAs are
potential first-to-file opportunities, representing $31.1 billion in annual brand sales, for the 12
months ending December 31, 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.
(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.