Mylan gets tentative FDA nod for generic Lipitor
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).
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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