Mylan Receives FDA Approval for Generic Version of Prostate Cancer Treatment Casodex(R)
07 Julho 2009 - 9:00AM
PR Newswire (US)
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 http://www.mylan.com/. DATASOURCE: Mylan
Inc. CONTACT: Michael Laffin, Media, +1-724-514-1968; Dan
Crookshank, Investors, +1-724-514-1813 Web Site:
http://www.mylan.com/
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