PITTSBURGH, Nov. 5, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq:
MYL) today announced the U.S. launch of its Norethindrone Acetate
and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous
Fumarate, which is the generic version of Warner Chilcott's Loestrin 24 Fe®.
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 in women who elect to use oral contraceptives as a method
of contraception.(1) Mylan has begun shipping product.
Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1
mg/0.02 mg and Ferrous Fumarate had U.S. sales of approximately
$24.4 million for the 12 months
ending September 30, 2014, according
to IMS Health.
Currently, Mylan has 287 ANDAs pending FDA approval representing
$112.2 billion in annual brand sales,
according to IMS Health. Forty-three of these pending ANDAs are
potential first-to-file opportunities, representing $29.3 billion in annual brand sales, for the 12
months ending June 30, 2014,
according to IMS Health.
Mylan is a global pharmaceutical company committed to setting
new standards in health care. 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 1,300 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 approximately 140 countries and
territories. Our workforce of more than 20,000 people is dedicated
to improving the customer experience and increasing pharmaceutical
access to consumers around the world. 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.
SOURCE Mylan Inc.