Mylan Inc.'s subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (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.
Mylan CEO Heather Bresch said: "We are very pleased to have received final approval for our ANDA for generic Lipitor, the most widely prescribed drug in US history. Through Mylan's launch of atrovastatin calcium tablets, we look forward to be able to offer our customers, the American consumer and the US government significant savings and expanded access to this important product."
According to IMS Health, Lipitor had US sales of $8.1 billion for the twelve months ending March 31, 2012. Mylan is shipping this product immediately.
Currently, Mylan has 171 ANDAs pending FDA approval representing $84 billion in annual sales, according to IMS Health. Thirty-eight of these pending ANDAs are potential first-to-file opportunities, representing $25.5 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.