FDA grants Mylan tentative approval for Atorvastatin Calcium ANDA

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.

Currently, Mylan has 173 ANDAs pending FDA approval representing $98.5 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $26.8 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health.

Source:

Mylan Inc.

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