In August U.S. drug regulators awarded Dr. Reddy's a so-called 180-day exclusive period for the 40-milligram generic version of Eli Lilly's Prozac, which had just come off patent (Barr Labs gained the license for the much-better-selling 20-milligram dosage).
Nissen of the Cleveland Clinic, compared the 80-milligram dose of Lipitor to the 40-mg dose of Bristol's Pravachol.
But although the high, 80-milligram dose of Lipitor cut heart attacks compared to the 10-mg starting dose, the increased dose did not cut down on the total number of deaths.
Forest says clinical trials involving 1, 100 patients show that a low, 10-milligram dose of Lexapro is as effective at relieving depression as a 40-mg dose of Celexa.
In data announced here at the annual meeting of the American College of Cardiology and published online in The Journal of the American Medical Association, Crestor, given at its top 40-milligram dose for two years, actually cleared plaque out of the arteries--something no marketed drug has been shown to do.
Not only is it non-sedating, but a 200-milligram dose is being tested for both men and women.
Barr gained a 180-day exclusivity, starting last August, to market a 20-milligram capsule generic version of the antidepressant.
To make things worse, the high, 80-milligram dose of the drug will probably not make it to pharmacy shelves.
They also said the side effects were in line with previously known side effects for the top 80-milligram dose of Zocor.
Merck says only 12% of patients were taking the 80-milligram dose, however.
FORBES: FDA Limits High-Dose Zocor, Backing Earlier Concerns For Second-Most Prescribed Drug
He also suggests that weaknesses in the FDA's surveillance of approved drugs may have let the risks of the 80-milligram dose slip by unnoticed.
John Alexander, global head of research at Daiichi Sankyo, says the FDA asked for an analysis of whether a lower five-milligram dose could help these patients.
Generic drugmaker Ranbaxy Laboratories will make the biggest, 80-milligram dose, which is rarely used because of an increase in side effects with high doses of the drug.
In one early test of the medicine, which must be injected, patients whose cholesterol was still too high on the 10-milligram dose of Lipitor had their Lipitor dose upped to 80 mg.
FORBES: New Drug Leads To Dramatic Reductions In Bad Cholesterol
In a letter sent to AstraZeneca, an officer at DDMAC noted that the efficacy of Crestor's top 40-milligram dose was similar to that of 80 milligrams of Lipitor in the study referenced by AstraZeneca.
Yesterday the Food and Drug Administration told doctors to stop prescribing the top 80-milligram dose of simvastatin, also known by the brand name Zocor, to new patients because of a heightened risk of muscle pain.
FORBES: The Scary Thing About the FDA's Simvastatin Decision
Since experimental evidence has suggested that antioxidants consumed orally, such as beta carotene, can reduce signs of sun-related skin damage, the study also looked at whether a daily 30-milligram beta carotene supplement could protect against skin aging.
In that study, 53 patients on the most potent 80-milligram dose of Zocor developed serious muscle weakness called myopathy, one of the recognized side effects of cholesterol drugs, and seven developed a more serious muscle problem called rhabdomyolysis.
Merck withdrew the 160-milligram top dose of Zocor from consideration at the U.S. Food and Drug Administration, Nissen writes, because of muscle-weakening side effects, which it may have caused more than 5% of the time--data that was not publicized.
The Food and Drug Administration instituted the new limit on the top 80-milligram dose of Zocor, generically known as simvastatin because that dose has been associated with an elevated risk of muscle injury, which can lead to potentially dangerous consequences.
FORBES: FDA Limits High-Dose Zocor, Backing Earlier Concerns For Second-Most Prescribed Drug
While the FDA is saying new patients should not be started on the 80-milligram dose, it is not saying that those who have been taking the medicine should switch, because the side effects are most likely in the first year of treatment.
FORBES: FDA Limits High-Dose Zocor, Backing Earlier Concerns For Second-Most Prescribed Drug
In the 4, 162-person PROVEIT study, Harvard cardiologists found that patients hospitalized for heart attacks or unstable angina who took a 80-milligram dose of Lipitor were 16% less likely to suffer heart attacks or other cardiovascular "events" over two years than those who took a lower dose of Bristol-Myers Squibb 's (nyse: BMY - news - people ) Pravachol.
In a dose-ranging study presented at the American College of Cardiology in March, patients who received the top 120 milligram dose of ETC-1002 saw their LDL decrease by a still-respectable 27%.
FORBES: As Companies Abandon Cholesterol, An Old Player Re-Emerges
In a Canadian study with lorcaserin, such test subjects only found altered effects with the 40 and 60 milligram doses, four- and six times higher than the recommended dose.
Which is why this slide, which shows the data for every patient in the study to received the 600 milligram dose of VX-809 both by itself (during a run-in phase) and with Kalydeco is the best argument so far that this combo is helpful to patients thought not as helpful as Kalydeco is to those who can get that drug alone.
FORBES: The Best Argument That Vertex's CF Drug Combination Works
Crestor still may find its niche: Milligram per milligram, it is the most powerful single-agent cholesterol pill on the market.
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