THURSDAY, Dec. 1 (HealthDay News) -- 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.
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.
The drug will be manufactured by Ohm Laboratories in New Brunswick, N.J.
and information about the availability of generic atorvastatin can be obtained from Ranbaxy.
To learn more about this approval, visit the FDA.