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Raids in Europe Crack Ring Selling Counterfeit Acomplia on Internet
2007-08-18 13:30:00
Simultaneous police raids conducted on April 24, 25 and 26 involving five Europe an countries resulted ?in the dismantling of a network of internet sales of counterfeit pills of the drug Rimonabant (Acomplia),? according to Eurojust, the European Union?s Judicial Cooperation Unit. The investigation, initiated by the public health department of the Paris public prosecutor?s office, led ...
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Generic Version of Diet Drug Rimonabant (Acomplia / Zimulti) Launched in In
2007-08-18 13:29:00
Zydus Cadila, an Indian manufacturer of generic drugs headed by one of the country?s richest men, said on May 17th it has launched a version of the new Sanofi-Aventis diet drug Acomplia (rimonabant) under the name Slimona. ?Slimona (Rimonabant) is a selective CB1 Endocannabinoid (EC) receptor antagonist indicated for the treatment of obesity,? Zydus Cadila said ...
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Sanofi ?Examining Options? Against Sellers Offering Generic Rimonabant (Aco
2007-08-17 17:59:00
Sanofi-Aventis, developer of diet drug rimonabant (Acomplia / Zimulti), said on May 24th it was ?examining all legal options? in light of the emergence of three different companies offering generic versions of rimonabant in India. The development puts Sanofi in the odd position of facing generic competition that could spread worldwide via the internet even as ...
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2d Generic Version of Diet Pill Rimonabant (Acomplia / Zimulti) Launched in
2007-08-17 17:59:00
A second Indian pharmaceutical company, Torrent Pharmaceuticals Ltd., has announced that it also is selling a generic version of the new Sanofi-Aventis diet drug Acomplia (rimonabant) under the name Rimoslim. The news, which attracted little attention in the West, occurred almost simultaneously with last week?s announcement by Zydus Cadila, an Indian manufacturer of generic drugs headed ...
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Do Indian Versions of Diet Drug Rimonabant Work the Same as Acomplia?
2007-08-17 17:58:00
With several mid-sized Indian pharmaceutical companies now selling a drug in India that they say is rimonabant, how likely is it that these drugs work exactly the same way as the Sanofi-Aventis drug Acomplia? That, of course, is always the question when drug companies bring out a generic ? an imitator of the innovator drug ? ...
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FDA Action on Rimonabant (Acomplia / Zimulti) May Be Slowed by Avandia Scar
2007-08-17 17:58:00
With a U.S. FDA advisory panel hearing on diet drug rimonabant (Acomplia / Zimulti) fast approaching, analysts are beginning to speculate that a recent rash of drug scares may weigh against early approval of sale of the diet pill in the United States. Bear Stearns analysts said the new concerns raised in the past 10 days ...
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Added Health Claims for Diet Drug Acomplia / Zimulti Questioned by Experts
2007-08-17 17:47:00
Claims that diet drug rimonabant (Acomplia / Zimulti) offers benefits beyond those associated with weight loss may not be justified, according to a new report by independent British medical experts. The diet drug has been sold as Acomplia in the U.K. since June 2006 for treatment of obese and some overweight adults, and developer Sanofi Aventis ...
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Diet Pill Rimonabant (Acomplia / Zimulti) Now on Sale in United Arab Emirat
2007-08-17 17:40:00
Diet drug rimonabant (Acomplia / Zimulti) is now available in the United Arab Emirates for treatment of abdominally obese patients with cardiometabolic risk factors, according to a June 4th announcement by developer Sanofi-Aventis. This is the first announced launch of Acomplia in the Middle East. The drug has been available for almost a year in Europe, ...
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Diet Pill Rimonabant (Acomplia / Zimulti) Facing Moment of Truth in Week Ah
2007-08-17 17:40:00
Diet drug rimonabant (Acomplia / Zimulti) faces its moment of truth in the United States during the week ahead. On Tuesday, June 12th, the FDA staff will for the first time reveal its views on the long-delayed diet drug. The following day, June 13th, the agency?s Endocrinologic and Metabolic Drug Advisory Committee, a panel of outside experts, ...
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FDA Delay on Diet Pill Acomplia (Rimonabant) Tied to Suicide, Seizures
2007-08-17 17:39:00
The long delay in FDA action on diet drug rimonabant (Acomplia / Zimulti) is the result of concern over ?increased frequencies of psychiatric adverse effects? including suicide and seizures, the agency?s staff disclosed on June 11th. The confirmation of long-rumored FDA worries over the neuropsychiatric side-effects of this novel diet drug ? which works by blocking ...
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FDA: 30 Percent of U.S. Patients on Diet Drugs Also Take Antidepressants
2007-08-17 17:39:00
While Sanofi-Aventis says patients on antidepressants should not take diet-drug rimonabant (Acomplia / Zimulti), the FDA says data it obtained for 2004-2006 showed that 30 percent of the 580,000 patients prescribed diet pills each year received a concurrent prescription for an antidepressant drug. The fact that many people who purchase prescription diet drugs appear to also ...
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Zimulti Acomplia Report Covers FDA Panel Meeting on Diet Pill Rimonabant
2007-08-17 17:38:00
The make-or-break FDA advisory panel meeting on diet drug rimonabant (Acomplia / Zimulti) will be the subject of team coverage on June 13th by staff of the Zimulti Acomplia Report , leading independent source of news about rimonabant. The day-long meeting, which will air concerns raised about ?rimonabant and increased rates of psychiatric adverse events, including depression ...
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Diet Drug Acomplia / Zimulti Dealt Blow as FDA Panel Says Keep It Off U.S.
2007-08-16 11:00:00
Diet pill rimonabant (Acomplia / Zimulti) was dealt a major setback on June 13th when an FDA advisory panel of outside experts unanimously recommended that the regulatory agency not approve the novel weight-loss drug for sale in the United States. The panel voted 14-to-0 that based on data provided to date, it was impossible to conclude that rimonabant has a “favorable risk-benefit profile,” and recommended that Zimulti — as it was to be known in the U.S. — not be approved to aid weight loss by obese and overweight individuals. “My level of concern regarding riminobant and psychiatric events is very high,” said Dr. Sid Gilman of the University of Michigan. Added Dr. Paul D. Woolf of Crozer-Chester Medical Center: “I am concerned about what we don’t know and the dangers we can fall into.” “We had better learn some more before we lunge into massive use,” said Dr. Jules Hirsch of Rockefeller University. “I wouldn’t in any way suggest that it be approved at the...
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Acomplia (Rimonabant) Safety Data to Be Reviewed by Europeans Next Week
2007-08-16 11:00:00
Safety data for diet pill Acomplia (rimonabant) will be reviewed by the European Medicines Agency (EMEA) next week after a U.S. panel of experts unanimously recommended against allowing the diet drug to be sold in the United States. More than 100,000 people in Europe have been prescribed the diet drug since the EMEA approved it for sale last year in the European Union. However, the FDA briefing June 13th of its Endocrinologic and Metabolic Drugs Advisory Committee included safety data submitted after European authorities approved Acomplia, and the strong concern expressed by the U.S. panel seems likely to lead to a more than routine review by European regulators. A regular meeting of the EMEA’s Committee for Medicinal Products for Human Use (CHMP) is set for June 18-21 and a spokesperson said Acomplia will “surely” be on the agenda in view of the serious safety concerns raised by the FDA experts. “If a big regulatory authority takes a decision or if such information comes to...
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Diet Drug Acomplia (Rimonabant) Users in Germany Get Bad News on Reimbursem
2007-08-16 10:59:00
Diet drug Acomplia users in Germany got bad news on June 20th when a Berlin court upheld a German regulatory body’s decision classifying rimonabant as a “lifestyle” drug not eligible for reimbursement by German state health insurers. The court upheld a decision by Germany’s Joint Federal Committee (G-BA) last October that Acomplia should be placed on the country’s negative list which specifies those products which are not reimbursed. A month’s supply of Acomplia in Germany runs about 100 Euros (U.S. $130). Nine out of 10 Germans are charged only a co-pay for drugs covered by state insurance, and in the case of Acomplia, the co-pay would have been about $10. Today’s court decision rejecting an appeal by Sanofi-Aventis means patients in Germany will have to pay for the entire cost of Acomplia out of their own pocket. Almost 50,000 Germans were prescribed Acomplia between June and November of last year, according to documents released last week in the U.S., making Germany...
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If You Want Acomplia (Rimonabant), You Won’t Find It Anywhere as Zimulti
2007-08-16 10:59:00
In the wake of the diet drug rimonabant (Acomplia / Zimulti) debacle on June 13th, there is no need for millions of Americans eager to try Acomplia to look for it under the new name Zimulti. Barring a miracle, rimonabant will not be approved by the FDA for sale in the United States — where developer Sanofi-Aventis intended to use the trade name Zimulti — for at least another two or three years. In Europe, the Middle East, Latin America, Mexico and all other countries (a total of 38 now) where the drug is either already on sale or where launch is pending, Sanofi’s rimonabant will continue to be sold as Acomplia. It was never Sanofi’s idea, of course, to change the name from Acomplia to the rather odd name Zimulti anyway. The FDA more than two years ago made it clear that it was not going to permit Sanofi to use the name Acomplia, which it thought was too suggestive that the drug would let overweight individuals “acomplish” their weight loss goal. But while Sanofi heard th...
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New European Recommendations on Diet Drug Acomplia May Be Published June 29
2007-08-16 10:58:00
A European regulatory review of diet drug Acomplia (rimonabant) may result in publication of new safety recommendations as early as June 29th, accordilng to a spokesperson for the European Medicines Agency (EMEA). The EMEA said it anticipates that comments of Acomplia will be included in the monthly report of its drug safety committee which is due out on Friday. The European review of Acomplia was triggered by the overwhelming vote of the U.S. Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee earlier this month recommending against sale of the diet drug in the United States based on currently available safety date. Acomplia is now widely available in Europe, where the diet drug was approved by the EMEA more than a year ago, and has been purchased by more than 100,000 Europeans. However, the U.S. advisory panel’s vote was based on newer data than that available to the EMEA a year ago — including data from post-marketing reports on usage in Eur...
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Diet Drug Acomplia (Rimonabant) Gets Reprieve in Europe
2007-08-16 10:58:00
Diet drug Acomplia (rimonabant) was discussed by Europe an regulators at their June meeting this week, but the only decision reached was to discuss the matter again at their July 16-to-19 meeting. The Committee for Medicinal Products for Human Use of the European Medicines Agency, which approved Acomplia for sale in Europe more than a year ago, said it will continue to review data on the diet drug, which has been purchased by more than 100,000 Europeans. The agency’s discussion of Acomplia this week followed the overwhelming vote by the U.S. Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee last week to recommend against sale of the diet drug in the United States based on currently available safety date. The advisory panel’s vote was based on newer data presented by FDA staff — including data from post-marketing reports on usage in Europe. The FDA is expected to go along with that recommendation in the next several weeks. While Acomplia for ...
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Sanofi Withdraws Bid to Sell Diet Drug Acomplia (Rimonabant) in United Stat
2007-08-16 10:57:00
The effort to get diet drug rimonabant (Acomplia / Zimulti) approved for sale in the United States temporarily ended on June 29th, when Sanofi -Aventis withdrew its application rather than await next month’s near-certain rejection by the U.S. Food and Drug Administration. The action followed the crushing vote two weeks ago of the FDA’s expert advisory committee, which unanimously recommended that sale of rimonabant not be permitted in the United States pending further study of rimonabant’s link to an increased risk of depression and suicidality. Sanofi, in a statement, said it would “undertake the necessary discussions with the FDA to determine” what additional data is needed before resubmitting its application, which will likely not occur until 2010. But, the company added, “Sanofi-Aventis is committed to making all efforts necessary to make rimonabant available to patients in the U.S. market.” Rimonabant, the first weight-loss drug which works by blocking CB-1 recepto...
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Sanofi: Diet Drug Acomplia Requires Indefinite Use to Keep Weight Off
2007-08-16 10:57:00
Diet drug Acomplia (rimonabant) users might want to pay close attention to an issue that developer Sanofi -Aventis is now facing the need to address more openly with regulators (if not dieters): If you want to keep off the weight you lose on Acomplia, you need to take the drug daily for the rest of your life. Marc Cluzel, senior vice president for scientific and medical affairs of Sanofi, told analysts Sanofi withdrew its application to sell rimonabant in the United States because it felt there would not be adequate time before July’s expected FDA decision to discuss issues raised by the FDA advisory panel linked to “duration of treatment.” In the Phase III clinical trials for Acomplia, patients who were on rimonabant for a year lost up to 10 percent of their body weight. But while those who continued on Acomplia for a second year maintained their weight loss, those switched to a placebo tended to quickly regain the weight. That would strongly suggest that to keep weight lost w...
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New Study Finds Diet Drug Acomplia May Help Reduce Liver Damage
2007-08-16 10:56:00
A new animal study on rimonabant (Acomplia / Zimulti) has identified yet one more possible health benefit for this controversial diet drug: it appears to reduce obesity-related liver damage that can lead to cirhossis of the liver. A team of researchers led by Mohammed Bensaid of Sanofi-Aventis, the company that has developed rimonabant, reported on these latest developments in the July 2007 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases. In their study involving liver function in obese rats, the researchers said they found that rimonabant reduced markers of liver damage, decreased levels of pro-inflammatory proteins, and improved lipid profiles. Male obese rats were given rimonabant orally daily for 8 weeks and had their food intake monitored; control animals received the same amount of food as those receiving rimonabant. The researchers reported the results showed treatment with rimonabant reduced liver enlargement, completely ...
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Diet Drug Acomplia to Remain on Sale in Europe With Stronger Warning
2007-08-15 11:24:00
Diet drug Acomplia (rimonabant) will remain on the market in Europe but will carry a stronger safety warning about psychiatric side-effects, European regulators decided on July 19th. The European Medicines Agency (EMEA) made the decision to let the diet drug remain on the market after reviewing safety data that led a U.S. FDA advisory panel last ...
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Europeans to Decide Whether to Further Restrict Diet Drug Acomplia This Wee
2007-08-15 11:24:00
Will diet drug Acomplia (rimonabant), taken this past year by more than 100,000 Europeans seeking to lose weight, be pulled from the European market out of concern over depressive and suicidal side-effects? That decision will be made known July 19th following this week?s safety review by the European Medicines Agency (EMEA) of data which led a ...
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Diet Drug Acomplia (Rimonabant) Doubles Risk of Depression ? European Regul
2007-08-15 11:23:00
Taking diet drug Acomplia (rimonabant) approximately doubles your risk of depression, and the risk may be even higher if you have a past history of depression, according to the European Medicines Agency (EMEA). ?This doubling of the risk of depression occurs in all types of patients,? the EMEA?s Committee for Medicinal Products for Human Use (CHMP) ...
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UK Regulator: 1 Person in 10 on Acomplia Experiences Psychiatric Side Effec
2007-08-15 11:23:00
Approximately one person in 10 taking diet drug Acomplia (rimonabant) experiences psychiatric side effects and about one person in 100 experiences suicidal thoughts, according to U.K. regulators. Of some 41,000 patients treated with rimonabant since it was launched in the U.K. in June 2006, 364 ?psychiatric reactions have been reported,? the Department of Health?s Medicines and ...
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Diet Drug Acomplia Sales Dwarfed by Initial Sales of Diet Pill alli
2007-08-15 11:22:00
Just how badly sales of diet drug Acomplia (rimonabant) have been set back by Sanofi?s inability to bring it to the U.S. market was dramatically illustrated July 25th when GlaxoSmithKline revealed initial launch results for over-the-counter diet pill alli (low-dose Xenical). Sales of non-prescription alli totaled a surprising $156 million in the weeks after its U.S. ...
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Sanofi Still Hoping Diet Drug Acomplia Will Make It to U.S. Market
2007-08-15 11:22:00
anofi-Aventis still believes there is a good chance diet drug Acomplia (rimonabant) ultimately will be approved by the U.S. Food and Drug Administration for marketing in the United States, according to the company?s head of German operations Heinz-Werner Meier. ?That subject has not yet been written off,? Sanofi ?s head of German operations Heinz-Werner Meier told the ...
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Sanofi Holds Little Hope for Early U.S. Sale of Acomplia / Zimulti (Rimonab
2007-08-15 11:21:00
Diet drug Acomplia / Zimulti (rimonabant) has now been taken by more than 200,000 obese and overweight patients in Europe and a handful of other countries, but Sanofi -Aventis offered no encouragement on Aug. 1 to those hoping to see it approved for early sale in the United States. Executive Vice President Hanspeter Spek, talking to financial ...
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Top Marketeer Returns to Merck to Promote Diet Drug Acomplia Competitor
2007-08-15 11:21:00
In the latest sign that things are going will with Merck ?s development of a competitor to diet drug Acomplia (rimonabant), the pharmaceutical giant is bringing back Len Tacconi to serve as global brand leader for its weight-loss drug taranabant. Tacconi, who left Merck less than a year ago to become president of Discovery Health, spent a ...
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Diet Drug Rimonabant May Reduce Obesity-Related Liver Damage
2007-08-15 11:20:00
A new study on rimonabant (Acomplia / Zimulti) has identified yet one more possible health benefit for this controversial diet drug: it appears to reduce obesity-related liver damage that can lead to cirhossis of the liver. A team of researchers led by Mohammed Bensaid of Sanofi-Aventis, the company that has developed rimonabant, reported on these latest ...
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