Mylan Launches Generic Version of Xopenex® Inhalation Solution

        Mylan Launches Generic Version of Xopenex® Inhalation Solution

PR Newswire

PITTSBURGH, March 18, 2013

PITTSBURGH, March 18, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its subsidiary Mylan Specialty L.P. has received final approval
from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug
Application (ANDA) for Levalbuterol Inhalation Solution USP, 0.31 mg/3 mL
(0.0103%), 0.63 mg/3 mL (0.021%), and 1.25 mg/3 mL (0.042%), (Concentrate).
This product is the generic version of Sunovion's Xopenex^® Inhalation
Solution, which is indicated for the treatment or prevention of bronchospasm
in adults, adolescents, and children 6 years of age and older with reversible
obstructive airway disease.

Levalbuterol Inhalation Solution USP, 0.31 mg/3 mL, 0.63 mg/3 mL, and 1.25
mg/3 mL, had U.S. sales of approximately $438.8 million for the 12 months
ending Dec. 31, 2012, according to IMS Health. Mylan has begun shipping this
product.

Currently, Mylan has 182 ANDAs pending FDA approval representing $80 billion
in annual sales, according to IMS Health. Thirty-six of these pending ANDAs
are potential first-to-file opportunities, representing $21.1 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 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.

Website: http://www.mylan.com
Contact: Nina Devlin (Media), +1-724-514-1968, or Kris King (Investors),
+1-724-514-1813
 
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