First Generic Lipitor Approved
THURSDAY Dec. 1, 2011 -- The first generic version of the cholesterol-lowering statin Lipitor (atorvastatin calcium) has been approved by the U.S. Food and Drug Administration.
Drug maker Ranbaxy Laboratories, based in India, has gained approval to produce the tablets in 10 milligram (mg), 20 mg, 40 mg and 80 mg strengths, the FDA said in a news release. The agency stressed that makers of generic drugs are required to pass the same production- and packaging-quality standards as producers of brand-name drugs.
People with above-normal levels of low-density lipoprotein (LDL, the so-called "bad" cholesterol), are at greater risk of heart attack and stroke when LDL levels build up in the arteries and inhibit blood flow. Lipitor blocks an enzyme in the liver, helping to lower levels of LDL and another form of blood cholesterol, triglycerides.
In clinical trials for the brand-name Lipitor, produced by Pfizer, the most common side effects included nasal inflammation, joint pain, diarrhea and urinary tract infection.
To learn more about this approval, visit the FDA.
Posted: December 2011