French pharmaceutical giant Sanofi-Aventis suffered a stinging stock market setback Thursday after a US panel said the company’s obesity treatment was unsafe and should not be marketed in the United States. Shares in the French company plunged 6.33 percent to 63.00 euros in closing deals on a Paris market that was 1.90 percent stronger.The 14 doctors on an advisory committee for the US Food and Drug Administration voted unanimously on Wednesday against allowing Sanofi’s diet drug to go on the US market, FDA spokeswoman Sandy Walsh said Wednesday.(buy zimulti)

During the FDA advisory committee hearing, several experts said the treatment appeared to be linked to an increase in suicidal thoughts among patients without a history of depression.The decision also amounted to a “unanimous 14 no vote about the safety of the drug,” the spokeswoman added.The FDA, which is not obliged to follow the panel’s recommendations but usually does, is expected to issue a decision on July 26.Analysts said a negative decision would mean losses of more than 2.5 billion euros (3.3 billion dollars,order cheap zimulti rimonabant) a year for the world’s fourth biggest pharmaceutical company.

Obesity is increasingly a central public health concern in industrialised countries and therefore a potentially huge market for pharmaceutical treatments.Often presented as a “miracle pill,” Acomplia, which treats obesity and related conditions like diabetes and high cholesterol, was developed in the 1990s by researchers led by Gerard Le Fur, who has been general director of the company since the beginning of the year.

The anti-obesity drug, which Sanofi-Aventis planned to sell in the United States under the brand name Generic Zimulti, is currently authorised in 37, mainly European Union, countries and sold in 18.The US market is a key outlet but Sanofi has encountered a series of pitfalls there.The group has never communicated its commercial forecasts for the United States, limiting itself to saying it was counting on three billion euros in worldwide sales.Sanofi-Aventis said it would continue to work closely with the FDA to address the concerns raised by the expert panel. A Sanofi spokesman in Paris declined further comment.

The company had hoped to get US approval in 2006 and planned to put it on the market shortly afterwards,But the FDA, which asked for more and more information on the drug, proved to be tougher than the company had expected.The US ruling could have a knock-on effect as the European Medicines Agency (EMEA,buy cheap zimulti), a European body for the evaluation of medicinal products, said Thursday it would try to determine if there were any “new information” regarding Acomplia.A spokesman said that the situation would likely be raised at an EMEA committee meeting from June 18-21.Some analysts said Sanofi could now be obliged to review ongoing clinical trials.Sanofi has already taken generic pharmaceutical producers to court in the United States for allegedly breaching its patent protection for the anticoagulants Lovenox and Plavix.It earns 2.4 billion euros a year from Lovenox and 2.2 billion euros from Plavix.The company has appealed a first court ruling which went against it. If it also loses its appeal it will permanently lose its patent protection for Lovenox.But industry analysts said they expected Sanofi to prevail in the case.

Slimming Pills Slimming pills, diet pills, appetite suppressants - all these are various names for weight loss aids. You will find many slimming pills online; some are available by prescription while some are available over the counter. If you want prescription slimming pills, buy Acomplia Rimonabant. These slimming pills come to the rescue of people who can’t quite make it with conventional methods such as dieting and exercising. If you have spent hours going to the gym, doing aerobics, weight training and other such activities but never reached the ideal body shape goals, buy Acomplia rimonabant. You should also buy rimonabant if crash diets and veggie salads have not helped you to lose even a single pound. Acomplia slimming pills help you to lose weight safely and effectively. If you are having a tough time burning some of your excess pounds, buy Acomplia slimming pills and lose weight. When you buy Acomplia, it will help you to manage your weight by making you eat less than you are eating at present. Acomplia slimming pills directly works by binding itself to the receptors in the brain and blocking to chemicals which stimulate hunger. This action of Acomplia slimming pills make you feel satisfied even with less food and as a result you lose weight. You should buy Acomplia rimonabant to lose weight, improve cardiovascular health and the health of your heart by reducing abdominal fat. Acomplia Rimonabant also boosts the levels of “good” HDL cholesterol in the blood by 27 percent in people who buy Acomplia online. You can buy rimonabant only if you have a BMI of 30 kg/m2, or are overweight with BMI of 27 kg/m2 with associated risk factors such as type II diabetes or dyslipidemia. If you are not dangerously overweight or obese, you doctor may not allow you to buy Acomplia. If however, you doctor allows you to buy Rimonabant, the first thing you need to know about is its side effects. Nausea, headache, irritability and dizziness are certain side effects you might experience after you buy Acomplia rimonabant. Many people who buy rimonabant suffer from depression, if you are taking antidepressants or have major depressive illnesses; it is advisable you don’t take this slimming pill before informing your doctor, family members and caregivers. It is very important to follow a diet and exercise program during and after you buy rimonabant slimming pills to achieve significant weight loss. The safety and efficacy of these slimming pills when used for more than two years has not been studied.

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Beware of Generic Acomplia Rimonabant Zimulti available in Market now However there are now websites offering generic Acomplia to US and UK customers. In nearly all cases the medication is coming from developing countries such as India and China. The manufacturers of these generics are not covered by any medical authority or body and as a result the ingredients in the drug may differ from what they claim which can lead to serious health risks. We Strictly offer Branded Acomplia Rimonabant which is manufactured by Sanofi-Aventis. Rimonabant is sold under the brand name Acomplia in Europe and by the brand name Zimulti in USA. EU Union has approved Acomplia for weight loss treatment but Zimulti is still waiting for the approval in USA from FDA. Rimonabant Acomplia Helps With Weight Loss Rimonabant acomplia is an anorectic anti obesity drug. It is a CB1 cannabinoid receptor antagonist.Rimonabant: A Miracle Fat-Fighting Drug Imagine a drug that melts fat, boosts good cholesterol while reducing artery-choking triglycerides, and helps smokers kick the habit. What sounds almost too good to be true could soon be just a prescription away. Rimonabant is the first drug designed to affect your endocannabinoid system, which influences energy balance, fat storage, cholesterol, and blood-sugar levels. In 2005, U.S. and European researchers reported 2-year results from rimonabant studies that are nothing short of astonishing. In the American trial, 3,040 volunteers were put on a reduced-calorie diet. Some were given the drug; others, a placebo. After 2 years, the waistlines of volunteers on rimonabant were more than 3 inches smaller (compared with 1.5 inches in the placebo group); 30 percent lost more than a tenth of their body weight (purchase acomplia-rimonabant,compared with 16 percent with the others). Acomplia without prescription NEW YORK: Do fat pills work? Are they safe? Dr. CELESTE ROBB-NICHOLSON : Scientists are studying factors that influence how full we feel and how fast we burn calories. Prescription weight-loss drugs–which include phentermine (purchase cheap rimonabant,sold as Adipex-P and other brand names), sibutramine (Meridia) and orlistat (Xenical,purchase rimonabant)–can temporarily manipulate some of these factors. Another new drug, acomplia without prescription, which blocks an appetite receptor in the brain, is awaiting approval from the Food and Drug Administration. (And Xenical may be available over the counter later this year.) The National Institutes of Health recommends that weight-loss drugs be given only to people with a body-mass index (BMI) over 29–or 27, if the patient has weight-related problems like type 2 diabetes, high blood pressure or arthritis.

Acomplia-(Rimonabant), a very effective weight loss drug for those patients who are fighting their battle with obesity, been approved for use in Europe from June 2006, but has yet to be approved in the United States due to its side effects like anxiety, depression and insomnia.
Acomplia-(Rimonabant), known in the United States as Zimulti, is a weight loss drug that was approved for use in Europe in June of 2006, but has yet to be approved in the United States. Acomplia-(Rimonabant) is the first Cannabinoid-1 Receptor Blocker, a new line of obesity drugs that work by blocking the Canabinoid-1 (CB-1) receptor found in the brain and other organs. Blocking this receptor seems to decrease cravings for food while aiding in the metabolizing of both glucose and fats. As a result, less fat is stored in the body because the patient not only eats less but also metabolizes the food that is eaten properly. As a side benefit, those who are on Acomplia-(Rimonabant) are often able to stop smoking because the drug curbs the craving for nicotine in the same way in which it stops the craving for food. The drug was discovered and then developed by the Safino-Aventis pharmaceutical company.

Why Is Acomplia-(Rimonabant) not Approved in the United States?

Acomplia-(Rimonabant) has been very effective for patients who are looking to shed unwanted weight in Europe, yet the drug has not been approved for use in the United States. In fact, as of June of 2007, the Food and Drug Administration in the U.S. (FDA) has unanimously voted not to accept the drug in the United States without further testing. Their reasoning is that there are too many potentially dangerous side effects that have not been addressed.

In clinical trials, patients who were on the medication reported twice as many psychiatric problems after taking the drug than those taking a placebo. These problems included anxiety, depression, and insomnia. Some patients were more susceptible to suicidal thoughts, which was a major cause for concern to the members of the FDA advisory panel that was assessing the drug. The FDA was also concerned about approving the
drug because of the intense market for anti-obesity drugs in the United States. The panel that studied the drug felt that the promise of weight loss would make many overweight consumers turn to the drug without considering the psychological risks.

Reason Behind the Side Effects

Part of the reason behind these potential side effects of Acomplia-(Rimonabant) is the way it affects the body. The CB-1 Receptor that is blocked by the drug is sometimes referred to as the “pleasure receptor.” When it is blocked, cravings for food are stopped because food does not bring the pleasure it used to bring. However, blocking the pleasure receptor has unknown consequences to the emotional and mental health of the patient, especially when done for a long period of time. For this reason, it is believed, some patients develop suicidal thoughts and dangerous depression. Mood swings are also a potential side effect. Two patients who were on Acomplia-(Rimonabant) for an extended period of time developed amnesia, which could have been from the drug.

The Rebuttal

While the FDA weighs the potential benefits and risks of this new weight loss drug, Sanofi-Aventis points out that the benefits far outweigh the potential risks. Patients who were on the drug during the clinical trials phase were able to lose 5% more weight than those who were on a placebo after a year. Even the FDA acknowledged that the drug produced meaningful weight loss results. The weight loss in these patients was often in the waist area, which is significant because too much excess weight in the abdominal area is a precursor to heart disease. Also, those who took Acomplia-(Rimonabant) lowered their blood glucose and blood pressure levels while increasing the good cholesterol in their bodies.

While depression is a potential side effect to the drug, the number of patients who experienced severe depression was small, and those patients could have had a tendency towards depression that had not been diagnosed prior to taking the drug.

Another argument in favour of the drug is its intended use. Like surgical obesity treatments, Acomplia-(Rimonabant) is intended only for those patients whose obesity is causing them serious physical problems, such as heart disease. In fact, the European Commission only approved the drug to be used for patients with a body mass index of at least 30. For significantly obese patients who have tried traditional weight loss options without success, the potential side effects of weight loss drugs like Acomplia-(Rimonabant) may be an acceptable risk in comparison to potentially fatal medical conditions caused by obesity.

Will Acomplia-(Rimonabant) Be Approved in the United States?

At this point, it is unclear whether or not the drug will be approved for use in the United States. The FDA is waiting to see more long-term studies on the side effects of the drug in order to gain a more thorough understanding of what patients on this drug are truly risking. Sanofi-Aventis and the FDA are currently discussing what needs to be done to proceed with the application for approval. While the drug has not yet been approved, there is still hope that a future approval may happen, which is good news to those unsuccessfully fighting their battle with obesity.