PITTSBURGH, Nov. 13, 2012 /PRNewswire/ -- Mylan Inc.
(Nasdaq: MYL) today announced that its subsidiary Mylan
Laboratories Limited has received final approval from the U.S. Food
and Drug Administration (FDA) for its Abbreviated New Drug
Application (ANDA) for Sildenafil Citrate Tablets, 20 mg. This
product is the generic version of Pfizer's Revatio®, which is
indicated for the treatment of pulmonary arterial hypertension in
adults to improve exercise ability and delay clinical
worsening.
Revatio Tablets, 20 mg, had U.S. sales of approximately
$338.7 million for the 12 months
ending September 30, 2012, according
to IMS Health. Mylan has begun shipping this product.
Currently, Mylan has 172 ANDAs pending FDA approval representing
$79.5 billion in annual sales,
according to IMS Health. Thirty-five of these pending ANDAs are
potential first-to-file opportunities, representing $21.2 billion in annual brand sales, for the 12
months ending June 30, 2012,
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 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 1,100 generic pharmaceuticals and several brand
medications. In addition, we offer a wide range of antiretroviral
therapies, upon which approximately one-third 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 150 countries and territories. Our
workforce of more than 18,000 people is dedicated to improving the
customer experience and increasing pharmaceutical access to
consumers around the world. But don't take our word for it. See for
yourself. See inside. mylan.com
SOURCE Mylan Inc.