PITTSBURGH — Mylan Inc. has released atorvastatin calcium tablets, a generic version of Pfizer’s Lipitor tablets for treating high cholesterol.
Mylan said Tuesday that its Mylan Laboratories Ltd. subsidiary has been cleared by the Food and Drug Administration to market atorvastatin calcium tablets in strengths of 10 mg, 20 mg, 40 mg and 80 mg.
The company had received tentative FDA approval for the product earlier this year.
"We are very pleased to have received final approval for our ANDA [abbreviated new drug application] for generic Lipitor, the most widely prescribed drug in U.S. history," stated Mylan chief executive officer Heather Bresch. "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."
Atorvastatin is indicated as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia to reduce elevated total cholesterol, LDL and triglycerides as well as to increase HDL cholesterol.
Lipitor had U.S. sales of $8.1 billion for the 12 months ended March 31, according to IMS Health data cited by Mylan.
