Mylan Launches Generic Zomig® Tablets
PITTSBURGH, May 15, 2013
PITTSBURGH, May 15,2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its subsidiary Mylan Pharmaceuticals Inc. has received final
approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated
New Drug Application (ANDA) for Zolmitriptan Tablets, 2.5 mg and 5 mg. This
product is the generic version of IPR Pharmaceuticals Inc.'s Zomig^® Tablets
and is indicated for the acute treatment of migraine with or without aura in
adults. Zolmitriptan Tablets are for use only where a clear diagnosis of
migraine has been established. If a patient does not respond after the first
dose, a healthcare provider should reconsider the diagnosis before
re-administering. The product is not indicated for the prevention of migraine
attacks or cluster headaches.
Zolmitriptan Tablets, 2.5 mg and 5 mg, had U.S. sales of approximately $152.8
million for the 12 months ending March 31, 2013, according to IMS Health.
Mylan has begun shipping this product.
Currently, Mylan has 178 ANDAs pending FDA approval representing $83.1 billion
in annual sales, according to IMS Health. Thirty-four of these pending ANDAs
are potential first-to-file opportunities, representing $22.4 billion in
annual brand sales, for the 12 months ending June 30, 2012, according to IMS
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 approximately 1,100 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. But don't take our word for it. See for yourself.
See inside. mylan.com
SOURCE Mylan Inc.
Contact: Nina Devlin (Media), 724.514.1968, or Kris King (Investors),
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