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Mylan Launches Generic Dilantin® Chewable Tablets



              Mylan Launches Generic Dilantin® Chewable Tablets

PR Newswire

PITTSBURGH, Dec. 28, 2012

PITTSBURGH, Dec. 28, 2012 /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 Phenytoin Chewable Tablets USP, 50 mg. This
product is the generic version of Pfizer's Dilantin® Chewable Tablets, which
are indicated for the control of generalized tonic-clonic (grand mal) and
complex partial (psychomotor, temporal lobe) seizures and prevention and
treatment of seizures occurring during or following neurosurgery. Phenytoin
serum level determinations may be necessary for optimal dosage adjustments

Phenytoin Chewable Tablets USP, 50 mg, had U.S. sales of approximately $16.5
million for the 12 months ending Sept. 30, 2012, according to IMS Health.
Mylan is shipping this product immediately.

Currently, Mylan has 185 ANDAs pending FDA approval representing $80.6 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.

Website: http://mylan.com
Contact: media, Nina Devlin, +1-724-514-1968, or investors, Kris King,
+1-724-514-1813, for Mylan Inc.
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