Mylan Receives FDA Approval for Generic Version of Prostate Cancer Treatment Casodex(R)

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Tue Jul 7, 2009 8:01am EDT

Mylan Receives FDA Approval for Generic Version of Prostate Cancer Treatment
Casodex(R)
Begins shipment of product

PITTSBURGH, July 7 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval
from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug
Application (ANDA) for Bicalutamide Tablets, 50 mg.

Bicalutamide Tablets are the generic version of AstraZeneca's prostate cancer
treatment Casodex(R), which had total U.S. sales of approximately $322 million
for the 12 months ending March 31 for the same strength, according to IMS
Health. Mylan has begun to ship this product.

Currently, Mylan has 118 ANDAs pending FDA approval representing $82.8 billion
in annual brand sales, according to IMS Health. Thirty-five of these pending
ANDAs are potential first-to-file opportunities, representing $16.7 billion in
annual brand sales, according to IMS Health.


Mylan Inc., which provides products to customers in more than 140 countries
and territories, ranks among the leading diversified generics and specialty
pharmaceutical companies in the world. The company maintains one of the
industry's broadest -- and highest quality -- product portfolios, supported by
a robust product pipeline; owns a controlling interest in the world's third
largest active pharmaceutical ingredient manufacturer; and operates a
specialty business focused on respiratory and allergy therapies. For more
information, please visit www.mylan.com.



SOURCE  Mylan Inc.

Michael Laffin, Media, +1-724-514-1968; Dan Crookshank, Investors,
+1-724-514-1813
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