(Reuters) - The U.S. Food and Drug Administration confirmed on Wednesday that it had given approval to Ranbaxy Laboratories Ltd to make the first generic version of the cholesterol-lowering drug Lipitor.
The FDA said in a statement late on Wednesday that the company would make generic atorvastatin calcium in 10, 20, 40 and 80 milligram tablets. Lipitor is made by Pfizer In.
The agency said the generic drug would be manufactured by Ohm Laboratories in New Brunswick, N.J.
Earlier on Wednesday, the FDA withdrew a press statement on the approval, saying it had been issued in error.
Approval for Ranbaxy to make a generic version of the largest-selling drug of all time came on the same day Watson Pharmaceuticals Inc launched an “authorized” version of Lipitor. Watson said early on Wednesday that it had begun shipping the pills, calling it the “largest generic product launch in U.S. history.”
Lipitor became available in 1997 and generated annual sales of $13 billion at its peak. It lowers “bad” LDL cholesterol and the risk of heart attack and stroke.
Shares of Pfizer closed up 3.4 percent at $20.07 on Wednesday.
Reporting by Vidya L Nathan in Bangalore