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Generic version of Lipitor receives tentative FDA approval

On February 2, 2012, Mylan Inc. announced the tentative U.S. Food and Drug Administration (FDA) approval of Atorvastatin Calcium. Atorvastatin Calcium is the generic version of Lipitor, a drug by Pfizer, Inc (research headquarters in Groton, CT) used for the prevention of heart disease and hypercholesterolemia (high cholesterol) and to reduce the risk of heart attack and stroke.

Heart disease is the leading cause of death in Connecticut. In one year alone, heart disease and stroke cost the residents of Connecticut an estimated $4.7 billion dollars in medical expenses and lost productivity. It kills roughly the same number of Americans each year as cancer, lower respiratory diseases (including pneumonia), and accidents combined.

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In the U.S., Lipitor had sales of $8.2 billion for the year 2011. Lipitor lost U.S. patent protection late last year, which exposes the drug to cheaper generic competition. Generic drugs are chemically the same as the original brand name drug and, for most patients, will work just as well. The difference is that generic drugs typically cost 20-80% less than the brand name drugs. 

Mylan, Inc. received tentative approval from the FDA for Atorvastatin Calcium Tablets, 10 mg, 20 mg, 40 mg, and 80 mg tablets. The approval of this generic version of Lipitor should slash the cost to patients, whether they have health insurance or not.

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, Hartford Health Examiner

Anita P. Kuan, Ph.D., resides in Connecticut where, as a medical writer, she develops articles for various media (i.e., magazines, reference books, medical journals). Though her passion is autoimmunity, she has written on a variety of topics ranging from medical procedures (e.g., splenectomy,...

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