Pfizer Starts Testing For Over-The-Counter Lipitor

Looking backward to improve its future, Pfizer will once again try to gain FDA approval to market its blockbuster drug, atorvastatin (Lipitor), over-the-counter (OTC). Peter Loftus reports in the Wall Street Journal that the company has started a clinical study to support the application for low-dose atorvastatin (10 mg). … Click here to read the full post on Forbes….

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Packaging Defect Leads Merck To Recall All Lots of Liptruzet In US

Merck said today that it was recalling all lots of Liptruzet, its combination of the cholesterol-lowering drugs ezetimibe and atorvastatin, in the US. The company said the recall was due to a packaging defect which could potentially allow air and moisture to affect the quality of the drug, though the company said “the likelihood of the packaging…

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Low Rate Of Problems With Statins In Study Of Quarter Million Patients

A very large analysis of previously published studies finds that statins are generally safe and well tolerated, but helps confirm previous links to a small increased risk for diabetes and elevation of liver enzymes. Some statins were better tolerated than other statins and lower-dose statins were better tolerated than high dose statins. In a paper published…

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FDA Approves Combination Of Ezetimibe And Atorvastatin

The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin. Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a…

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Blood Sample Mismatch Leads ‘Anguished’ Authors To Retract Three Lipitor Papers

Three substudies of the influential TNT (Treating to New Targets) trial have been retracted after the sponsor of the trial, Pfizer, discovered that blood samples from the study had been matched to the wrong participants.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….

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Following Earlier Recall, Ranbaxy Halts Manufacturing Atorvastatin

Ranbaxy, the often-troubled manufacturer of generic drugs, will temporarily stop manufacturing generic atorvastatin. On November 9, 2012 the company announced a voluntary recall of some lots of atorvastatin because of possible contamination with glass particles. An FDA statement today said that Ranbaxy will discontinue making the drug “until it has thoroughly investigated the cause of the…

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Atorvastatin Lifts Ranbaxy While Pfizer Abandons Its Lipitor Marketing Efforts

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…

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Statins and Diabetes: Real Concern or Much Ado About Nothing?

Updated at 7 PM with a detailed comment at the bottom from C. Michael Minder of Johns Hopkins– In a New York Times Op-Ed piece on Monday, Eric Topol comments on last week’s announcement by the FDA that it was changing the label for statins. Topol focuses on the new warning that statins raise the risk…

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