Mylan Receives FDA Approval for Generic Version of Prevacid(R) Through its Subsidiary Matrix Laboratories

Tue Nov 10, 2009 3:24pm EST
 
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Mylan Receives FDA Approval for Generic Version of Prevacid(R) Through its
Subsidiary Matrix Laboratories



PITTSBURGH, Nov. 10 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its privately held Indian subsidiary, Matrix Laboratories
Limited, has received final approval from the U.S. Food and Drug
Administration (FDA) for its Abbreviated New Drug Application (ANDA) for
Lansoprazole Delayed-release (DR) Capsules, 15 mg and 30 mg. This product is
shipping immediately and will be sold under the Mylan Pharmaceuticals brand.

Lansoprazole DR Capsules are the generic version of Tap Pharmaceuticals'
proton pump inhibitor Prevacid® DR Capsules. The brand product had U.S. sales
of approximately $3 billion for the 12 months ending June 30, according to IMS
Health.

Currently, Mylan has 125 ANDAs pending FDA approval representing $84.1 billion
in annual brand sales, according to IMS Health. Thirty-seven of these pending
ANDAs are potential first-to-file opportunities, representing $19.2 billion in
annual brand sales, for the 12 months ending June 30, 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 www.mylan.com.


SOURCE  Mylan Inc.

Michael Laffin (Media), +1-724-514-1968, or Dan Crookshank (Investors),
+1-724-514-1813, both of Mylan Inc.

 

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