Mylan Receives Tentative FDA Approval for Generic Version of Lipitor

Symbols: MYL
Posted in: News, FDA
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Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Atorvastatin Calcium Tablets, 10 mg (base), 20 mg (base), 40 mg (base) and 80 mg (base). Atorvastatin Calcium is the generic equivalent to Pfizer's Lipitor® Tablets, indicated for the prevention of cardiovascular disease and hypercholesterolemia.

Lipitor had U.S. sales of $8.2 billion for the twelve months ending Dec. 31, 2011, according to IMS Health.


 
 
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