AstraZeneca LP is suing several major drug manufacturers for overcharging consumers when their cholesterol-lowering drugs cost more than the generic equivalents of its top-selling cholesterol-lowering drugs.
“We are a very small minority of the market,” says Dr. Paul A. Ehrlich, astraZeneca’s chief medical officer.
In recent months, the U. S. Food and Drug Administration has launched a massive investigation into AstraZeneca’s overcharging of its drug-cheating drug cholesterol-lowering drugs. The company has already agreed to pay more than $4.3 billion to settle allegations that AstraZeneca overcharged doctors for drugs that were not covered by insurance plans. The probe is expected to continue.
Ehrlich’s $4.3 billion suit is the largest in its history. It is based on an investigation by the FDA, which began in 2008 and concluded that AstraZeneca’s top-selling cholesterol-lowering drug Crestor, which is sold by Merck & Co., had no prescription-drug benefit.
The FDA asked AstraZeneca to settle on behalf of the generic drug company, saying that the company had failed to pay for Crestor’s drug to treat a rare type of heart disease called type 2 diabetes.
Ehrlich says that “there is evidence that Crestor is safe for the use in patients who have certain conditions that are not treated with other drugs.”
In a statement, the FDA said that “the information presented by the FDA indicates that Crestor is safe for the treatment of type 2 diabetes.”
Ehrlich also says the company will have no comment on whether the drug’s label states Crestor’s risks as of February 14, 2025. He said that the FDA’s decision means that “there is no reason to believe that the generic Crestor would have been covered under a Medicare-approved plan” and that “this suit is not based on the existence of Medicare insurance coverage.”
He says that the FDA had not approved Crestor for use in patients who have diabetes, nor did it “specifically approve or advise of the benefits of Crestor in patients who have type 2 diabetes.”
Ehrlich says that he has obtained the AstraZeneca settlement from aNew York Timesarticle in the last month that it represents “an unparalleled fraud, a fraud on the American public and a fraudulent practice that could have gone far in the future.”
The suit is being filed byThe New York Timesadiq Nang, a managing director atof AstraZeneca. She is represented by her former U. partner, Daniel Watts.
In an email to The New York Times, Watts said, “We do not represent AstraZeneca’s legal position, and we are not the maker of this suit.”
The suit, filed on behalf of AstraZeneca, asks that the suit be settled with the FDA. It also asks that the AstraZeneca settlement bedismissed.
The company has already agreed to pay a total of $1.9 billion to settle all of its lawsuits and to pay $300 million to settle allegations that the company overcharged physicians who performed unnecessary or inappropriate work.
The company is also seeking approval from the U. Food and Drug Administration for the generic version of Crestor. AstraZeneca has already been granted a $3.5-billion settlement, and is also expected to be on the market for a different class of cholesterol-lowering drugs, which include Crestor.
“In our current effort to resolve this case, we have received multiple requests from the FDA,” said David J. Guggenblu, executive vice president for the firm’s pharmaceuticals division, in an e-mail. “This is an unprecedented opportunity for a drug company to pay for a drug that the FDA cannot afford.”
The AstraZeneca settlement is expected to be a $2.2-billion fine for the generic drug industry, which makes Crestor a top-selling cholesterol-lowering drug. It will add an additional $600 million to the total settlement of cases, including a $4.4-billion fine on the company’s failure to pay for Crestor.
Crestor works by reducing a certain enzyme within the body that produces cholesterol. It belongs to a class of medications called statins.
Cholesterol is a form of lipid, a waxy substance that helps your body make cells, vitamins, and certain hormones. It is not inherently bad. Your liver produces an enzyme that synthesizes cholesterol to help with the above healthy functions. Additional cholesterol is introduced to the body through certain foods like meat, poultry, and dairy products.
There are two types of cholesterol: high-density lipoproteins (HDLs) and low-density lipoproteins (LDLs). LDLs carry cholesterol throughout the body, delivering cholesterol to cells that need it. HDLs carry excess LDLs back to the liver, where they are broken down and flushed from the body. While LDLs play a key role in cell health, they build up when the body has more cholesterol than the cells need. This buildup turns into plaque in the arteries (blood vessels). As plaque covers the artery walls, the blood vessels become narrow. This makes it harder for blood to flow through the body, which can lead to heart disease and heart failure.
Statins work by reducing the production of cholesterol in the liver, which lowers the overall cholesterol levels in the body. Not only do statins decrease levels of LDLs in the body, but they can also raise the level of HDLs in the body. In effect, they keep the body from making too much of the “bad” cholesterol that builds up in arteries while increasing the amount of “good” cholesterol that carries the “bad” out of the body. This dual action has been shown, along with diet and exercise, to lower overall cholesterol levels in patients effectively.
cheapDo not takeStatins if you are allergic to rosuvastatin or become pregnant. Do not take a statin if you are currently using nitrate drugsulin in the treatment of angina (chest pain). Additionally, do not take a statin if you are currently using high blood pressure medication such as amyl nitrite (codeine) or isoprotteritable (prolonged-temperature)]. Amyl nitrite works by working to make the body more prone to muscle spasms and can worsen angina. This can occur 2 or 3 days prior to a planned activity or when the user has been advised against any induction of spasms.
Use with regard to diet and exercise. Do not exceed the recommended dose or duration of use. Limit alcohol intake and excessive caffeine consumption while using statins.
Tell your doctor if you have kidney disease or liver disease. Especially tell your doctor if you have heart disease, uncontrolled high blood pressure, or a history of gout (glucotrol saturation decrease).
Tell your doctor if you are pregnant or plan to become pregnant. Also, tell your doctor if you are breastfeeding or plan to breastfeed. It is especially important to tell your doctor if you are pregnant or plan to become pregnant.
Tell your doctor if you are breast-feeding. Also tell your doctor if you are pregnant, plan to become pregnant, or think you may be pregnant. While using these conditions, tell your doctor if you are breast-feeding or planning to breast-feed.
Do not useStatins together with Lipitor.
Show/untyp.AstraZeneca has agreed to pay $8.2 billion in cash to settle claims it agreed to pay billions of dollars in settlements and other payments to doctors who received Astra Zen drug Crestor from its manufacturer in the United States and Europe.
The payments, which are set to end in August, will be subject to a notice from the United States Food and Drug Administration (FDA) that would be published in the same issue of theInternational Journal of Medical Affairs.
The payments have already been approved by the FDA in several other countries, including the United States, Europe, Japan, Australia and Canada.
The agreements are part of the AstraZeneca's largest multi-national discount drug discount program since 2002, with a total $16.9 billion in cash payments totaling $6.3 billion.
In November, AstraZeneca paid $7.5 billion to settle over $15.9 billion in claims involving the company's products including Crestor and its generic version of Crestor.
The settlement resolves allegations that the company engaged in an illegal marketing of the drug by AstraZeneca in violation of the United States and European prescription drug regulatory authorities. The AstraZeneca settlement will be effective by the end of the year.
The settlement is not without a few caveats.
First, it does not provide a full accounting of the sales, marketing and use of the drugs in the United States and the other territories.
Second, AstraZeneca has agreed to pay $5 billion in cash to the states of New York, Massachusetts, Connecticut, New Jersey and Virginia. The payments are to cover the costs of litigation and to cover any future litigation over the drugs. In some states the payments will be limited to $500,000 in cash. In others it will only be used to cover the cost of litigation and to cover any future litigation over the drugs.
Finally, the settlements are in addition to any settlement for the rest of the company's drug portfolio, in which the company is also seeking to market its products.
About AstraZeneca
AstraZeneca was established in 1995 by AstraZeneca's founder and chairman Bill White and was the first pharmaceutical company to reach its full growth potential. In 2008, the company's shares were down 5 percent at $14.98 after the company announced the acquisition of US$4 billion in cash.
The company has been the world's leading pharmaceutical company since 2001. It has generated more than $14 billion in revenue from the company's worldwide operations, $9.2 billion in sales in 2009 and $5 billion in revenue from the sale of its U. S. brand name pharmaceutical company,Actavis
The company operates in approximately 140 countries and has more than 400,000 employees worldwide.
The company's products are made in its own generic form.
The company has an annual dividend of less than 10 percent. In 2010, the company earned $8.7 billion.
In the past 30 years, AstraZeneca has been one of the world's top-selling pharmaceutical companies. Over the past five years, the company's sales have grown by 8 percent and its profits have been more than double the value of any of the company's top-selling products.
In 2006, AstraZeneca's share of global sales reached a new all-time high of $10.6 billion.
In 2006, its revenue surpassed $11 billion in sales of all products in 2007. In 2006, the company earned $8.2 billion in sales.
In 2006, the company's shares were down 11 percent at $20.45, having lost price after the company announced a $1.1 billion deal with the Federal Trade Commission (FTC). In 2007, it earned $11.7 billion.
In 2008, the company earned $7.7 billion. In 2008, the company earned $6.6 billion.
In 2009, the company earned $1.7 billion. In 2009, the company earned $5.2 billion.
In 2009, the company earned $1.4 billion.
Medically reviewed by Jessica Swirble, PharmDLast updated on April 17, 2025
The American College of Surgeons recommends Crestor be prescribed to all patients with an enlarged prostate who have a recent or previous surgery to remove a blockage in the prostate. It's also not recommended for patients who have had radical prostatectomy or other radical prostatectomy procedures.
The National Institutes of Health advises that patients who have had prostatectomy and other radical prostatectomy procedures should be monitored closely for signs of fluid retention and electrolyte imbalance. A physician may recommend Crestor for such patients.
Stomach pain and nausea are also common side effects of Crestor. However, the medication may be well tolerated in most patients.
The FDA warns Crestor users to avoid alcohol and tobacco use, as they may interfere with its effectiveness and may increase the risk of side effects.
The FDA also advises that patients taking corticosteroid medications should not take more than one drug in a day. Patients should also report any severe side effects to their healthcare provider.
The FDA advises that patients with severe kidney disease should avoid Crestor, as this drug may increase the risk of adverse reactions.
The most common side effects reported by patients include weakness, numbness or tingling in the arms or legs, shortness of breath, and dizziness. Contact your healthcare provider if you notice unexplained weight gain, weight loss, unusual tiredness, weakness, dizziness, or other unexplained side effects.
The most common side effects reported by patients include difficulty breathing or swallowing, nausea, vomiting, stomach pain, and abdominal pain. Contact your healthcare provider if you experience unexplained weight gain, weight loss, unusual tiredness, weakness, dizziness, or other unexplained side effects.
Sharing …Read moreRecommended by 1 out of every 10 AdultsLast updated on April 17, 2025The information provided in this article is not intended, it is, and should not be used for diagnosing or treatment of a medical condition. It is not a substitute for individual needs.
Crestor (Rosuvastatin calcium)There are certain drugs that are commonly prescribed to Crestor patients who have a recent or previous surgery to remove a blockage in the prostate.
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