FDA approves first generic version of cholesterol-lowering drug Lipitor

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets). Ranbaxy Laboratories Ltd. has gained approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths. The drug will be manufactured by Ohm Laboratories in New Brunswick, N.J.

People who have high blood cholesterol levels have a greater chance of getting heart disease. By itself, the condition usually has no signs or symptoms. Thus, many people do not know that their cholesterol levels are too high.

"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 Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "We are working very hard to get generic drugs to people as soon as the law will allow."

Not all cholesterol in your blood is bad. There are three kinds of blood cholesterol that you should know about: high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides. HDL (good cholesterol) helps keep cholesterol from building up in the arteries. LDL (bad cholesterol) is the main source of cholesterol buildup and blockage in the arteries, which can prevent proper blood flow to your heart and lead to a heart attack. Triglycerides can lead to hardening of the arteries.

Atorvastatin is a statin, a type of drug that lowers cholesterol in the body by blocking an enzyme in the liver. Atorvastatin is used along with a low-fat diet to lower the LDL cholesterol and triglycerides in the blood. The drug can raise HDL cholesterol as well. Atorvastatin lowers the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as age, smoking, high blood pressure, low HDL, or family history of early heart disease.

In the clinical trials for Lipitor, the most commonly reported adverse reactions in patients were: inflammation of the nasal passages, joint pain, diarrhea, and urinary tract infection.

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.

Information about the availability of generic atorvastatin can be obtained from Ranbaxy.

Most Popular Now

GSK reaches agreement with Novartis to acquire ful…

GlaxoSmithKline plc (LSE/NYSE: GSK) today announces that it has reached an agreement with Novartis for the buyout of Novartis' 36.5% stake in their Consumer Healthcare Jo...

Canadian neuroscientists say daily ibuprofen can p…

A Vancouver-based research team led by Canada's most cited neuroscientist, Dr. Patrick McGeer, has successfully carried out studies suggesting that, if started early enou...

First proof a synthesized antibiotic is capable of…

A "game changing" new antibiotic which is capable of killing superbugs has been successfully synthesised and used to treat an infection for the first time - and could lea...

Merck partners with Medisafe to help improve medic…

Merck, a leading science and technology company, today announced a new collaboration with US-based Medisafe to help its cardiometabolic patients better manage medication ...

Phase III data in The Lancet show Novartis siponim…

Novartis today announced that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) w...

Taking a standard prostate cancer drug with food b…

By taking a high-cost drug with a low-fat meal - instead of on an empty stomach, as prescribed - prostate cancer patients could decrease their daily dose, prevent digesti...

North and south cooperation to combat tuberculosis

Tuberculosis can be cured and could be eradicated. For this to happen, however, patients have to receive the right treatment. Researchers at the Makerere University and t...

New immunotherapy for lung cancer shows promise of…

In a groundbreaking development, results from a recent clinical trial to treat lung cancer show that a novel immunotherapy combination is surprisingly effective at contro...

Boehringer Ingelheim and OSE Immunotherapeutics an…

Boehringer Ingelheim and OSE Immunotherapeutics, a biotechnology company focused on the development of innovative immunotherapies, have announced a collaboration and excl...

Personalized tumor vaccine shows promise in pilot …

A new type of cancer vaccine has yielded promising results in an initial clinical trial conducted at the Perelman School of Medicine at the University of Pennsylvania and...

Lokelma approved in the EU for the treatment of ad…

AstraZeneca today announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment...

New targeted therapy schedule could keep melanoma …

Skin melanoma, a particularly insidious cancer, accounts for the vast majority skin cancer deaths and is one of the most common cancers in people under 30. Treatment for ...