Mylan Inc. (MYL) announced Tuesday that its subsidiary Mylan Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application or ANDA for Atorvastatin Calcium Tablets, 10 mg, 20 mg, 40 mg and 80 mg.
Atorvastatin Calcium is the generic version of Pfizer's Lipitor Tablets, which are indicated as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia to reduce elevated total cholesterol, LDL, triglycerides and to increase HDL cholesterol.
Lipitor had U.S. sales of $8.1 billion for the twelve months ending March 31, 2012, according to IMS Health. Mylan is shipping this product immediately.
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