The U.S. Food and Drug Administration has granted Mylan Inc. tentative approval for atorvastatin calcium tablets, a generic version of Pfizer Inc.'s blockbuster Lipitor cholesterol-lowering medication.


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Mylan gets tentative approval for Lipitor generic

February 2nd, 2012

PITTSBURGH – The U.S. Food and Drug Administration has granted Mylan Inc. tentative approval for atorvastatin calcium tablets, a generic version of Pfizer Inc.'s blockbuster Lipitor cholesterol-lowering medication.

Mylan said Thursday that its Mylan Laboratories Ltd. subsidiary (former Matrix Laboratories Ltd.) has received tentative FDA clearance for its Abbreviated New Drug Application (ANDA) for atorvastatin calcium tablets in strengths of 10 mg (base), 20 mg (base), 40 mg (base) and 80 mg (base).

Atorvastatin calcium is indicated for the prevention of cardiovascular disease and hypercholesterolemia.

Lipitor had U.S. sales of $8.2 billion for the 12 months ended Dec. 31, 2011, according to IMS Health data cited by Mylan.

Other pharmaceutical companies that have launched or plan to release generic versions of Lipitor include Watson Pharmaceuticals, which rolled out an authorized Lipitor generic, as well as Ranbaxy and Teva Pharmaceuticals.

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