Mylan Receives Tentative FDA Approval for Atorvastatin Calcium Tablets
Atorvastatin Calcium is the generic equivalent to Pfizer's Lipitor Tablets, indicated for the prevention of cardiovascular disease and hypercholesterolemia.
Mylan Inc. announced Thursday that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. 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
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