Mylan Laboratories (formerly Matrix Laboratories) has received tentative FDA approval for abbreviated new drug application (ANDA) for Atorvastatin Calcium Tablets, 10mg (base), 20mg (base), 40mg (base) and 80mg (base).
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Atorvastatin Calcium tablets, generic version of Pfizer’s Lipitor tablets, is indicated for the prevention of cardiovascular disease and hypercholesterolemia.
According to IMS Health, Lipitor had US sales of $8.2bn for the twelve months ending 31 December 2011.
Mylan Laboratories is subsidiary of Mylan, a generic and specialty pharmaceutical company.
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