Mylan Laboratories, formerly Matrix Laboratories, has gained final FDA approval for its abbreviated new drug application (ANDA) of Atorvastatin Calcium Tablets of strengths 10mg, 20mg, 40mg and 80mg.
The company begins immediate shipment of the generic version of Pfizer's Lipitor tablets.
The generic product is 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.
Mylan CEO Heather Bresch said, "Through Mylan's launch of Atorvastatin Calcium Tablets, we look forward to be able to offer our customers, the American consumer and the U.S. government significant savings and expanded access to this important product."
According to IMS Health, for the twelve months ending 31 March 2012, Lipitor had US sales of $8.1bn.
