April 16th, 2013
Blood Sample Mismatch Leads ‘Anguished’ Authors to Retract Three Lipitor Papers
Larry Husten, PHD
Three substudies of the influential TNT (Treating to New Targets) trial have been retracted after the sponsor of the trial, Pfizer, discovered that blood samples from the study had been matched to the wrong participants. The main results of TNT, published in 2005 in the New England Journal of Medicine, had a major impact on clinical practice and statin prescription patterns. The […]
January 3rd, 2013
Combination of Ezetimibe and Atorvastatin Back on FDA Approval Path
Larry Husten, PHD
A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son […]
May 10th, 2012
Atorvastatin Lifts Ranbaxy While Pfizer Abandons Its Lipitor Marketing Efforts
Larry Husten, PHD
Pfizer will no longer aggressively market Lipitor (atorvastatin), its former crown jewel and the most lucrative pharmaceutical product ever. At the same time, generic drug manufacturer Ranbaxy posted record revenue for the last business quarter, growth fueled largely by sales of generic atorvastatin in the United States. Pfizer told the Wall Street Journal that it was abandoning efforts […]
November 30th, 2011
Generic Atorvastatin Hits the Market
Larry Husten, PHD
The first generic version of Lipitor (atorvastatin) became available today as the exclusive patent held by Pfizer finally expired. Lipitor was by far the most successful prescription drug in history. Watson Pharmaceuticals announced an authorized generic version. One other company, Ranbaxy, has been authorized to market atorvastatin, but has struggled to gain FDA approval of its manufacturing plant. The company has […]
August 4th, 2011
Pfizer Wants to Market OTC Atorvastatin (Lipitor)
Larry Husten, PHD
Pfizer will attempt to gain FDA approval to sell atorvastatin (Lipitor) over-the-counter, according to a report by Peter Loftus in the Wall Street Journal. In the past, the FDA has turned down requests to market other statins over-the-counter. Lipitor is scheduled to go off patent in November, well before an OTC version of the drug […]