Friday, 2 December 2011

Cholesterol-Lowering Lipitor: FDA Okays First Generic Version

The US Food and Drug Administration (FDA) announced on Wednesday that it has approved the first generic version of the world's top-selling medicine, the cholesterol-lowering drug Lipitor (atorvastatin), currently marketed by Pfizer Inc.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, has gained FDA approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths. The tablets will be made by Ohm Laboratories in New Brunswick, New Jersey, says the FDA.

A statement from Raxbaxy says Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of Ranbaxy Laboratories Ltd, will be marketing the generic atorvastatin in the US.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told the press the agency was "working very hard" to ensure patients get generic drugs as fast as the law will permit:

"This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options," said Woodcock.

The FDA notes that:

"Generic drugs approved by FDA have the same high quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs."

People with high cholesterol usually have a greater chance of developing heart disease. High cholesterol comes with no signs or symptoms, so many people don't know they have it.

Not all cholesterol is bad. There are three types worth noting for health reasons: high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides.

HDL, the so-called "good" cholesterol, actually helps prevent cholesterol building up on the insides of our arteries. LDL, the so-called "bad" cholesterol, is the one that sticks to artery walls, leading to build up which obstructs blood flow and increases the risk of heart attack. Triglycerides are linked to hardening of the arteries.

Atorvastatin, like other statins, lowers cholesterol in the body by blocking an enzyme produced by the liver. It is recommended for use with a low fat diet that lowers circulating LDL cholesterol and triglycerides. However, the drug also raises HDL cholesterol, thus producing a double effect.

Trials show that in people with heart disease, or risk factors for heart disease, atorvastatin reduces the risk of heart attacks, strokes, certain types of heart surgery and chest pains. Risk factors for heart disease include age, low HDL, smoking, high blood pressure and family history of early heart disease.

The most common side effects, found in trials for Lipitor, are inflammation of the nasal passages, pains in the joints, diarrhea, and urinary tract infection.

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