PITTSBURGH — Mylan on Tuesday announced that its subsidiary has received final approval from the Food and Drug Administration for its abbreviated new drug application for atorvastatin calcium tablets, a generic version of Pfizer's Lipitor.
The drug maker said Mylan Labs (formerly Matrix Labs) received the go-ahead to market the drug in the 10-mg, 20-mg, 40-mg and 80-mg strengths. Lipitor had U.S. sales of $8.1 billion for the 12 months ended in March, according to IMS Health.
"We are very pleased to have received final approval for our ANDA for generic Lipitor, the most widely prescribed drug in U.S. history," 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."