Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax(R) Sprinkle Capsules
15 October 2009 - 10:30PM
PR Newswire (US)
PITTSBURGH, Oct. 15 /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 Topiramate Capsules (Sprinkle), 15 mg and 25 mg.
Topiramate Capsules (Sprinkle) are the generic version of Ortho
McNeil's anticonvulsant Topamax® Sprinkle Capsules, 15 mg and 25
mg. For the 12 months ending June 30, 2009, Topiramate Capsules
(Sprinkle) had U.S. sales of approximately $58 million for the same
strengths, according to IMS Health. Mylan has launched this
product. Currently, Mylan has 121 ANDAs pending FDA approval
representing $85.7 billion in annual brand sales, according to IMS
Health. Thirty-four of these pending ANDAs are potential
first-to-file opportunities, representing $17.9 billion in annual
brand sales, according to IMS Health. Mylan Inc. ranks among the
leading generic and specialty pharmaceutical companies in the world
and provides products to customers in more than 140 countries and
territories. The company maintains one of the industry's broadest
and highest quality product portfolios supported by a robust
product pipeline; operates the world's third largest active
pharmaceutical ingredient manufacturer; and runs 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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