Owner: Rimonabant acomplia, weight loss pill. URL:http://rimonabantacomplia.cc/ Join Date: Mon, 13 Aug 2007 05:47:40 -0500 Rating:0 Site Description: Information about rimonabant, also known as acomplia or zimulti. Site statistics:Click here
Diet Pill Acomplia Now Widely Available in Mexican Border Pharmacies 2007-08-13 05:42:48 Diet drug Acomplia (rimonabant), which seems at best months away from sale in the United States, is now widely available in pharmacies just across the Mexican
border.
Readers increasingly are sending us reports on their experiences purchasing the highly anticipated diet pill in Mexican towns just across the border from California, Arizona, New Mexico and Texas.
In contrast to our last report on this back in March, when many Mexican pharmacies had not heard of Acomplia or had not received it yet, the latest reports suggest that if you stumble across a pharmacy that does not have it in stock, all you probably need to do is check the pharmacy across the street.
A sampling of Mexican prices for the diet drug found most hovering right around $117 for the standard package of 28 pills, making purchases in Mexican border towns — if you live nearby — a less expensive option than purchasing the diet pill by mail order from Europe.
The lowest price we have heard of in a Mexican pharma Read more:Border
Diet Pill Rimonabant Now On Sale On United Arab Emirates 2007-08-13 05:41:44 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, and also is on sale in Argentina, Brazil and Mexico.
A recent survey found that 37 percent of the UAE population is now obese — one of the highest obesity rates in the Middle East, according to Sanofi.
“Among people who are overweight or obese, it is those with excess fat around their abdomen who are at the greatest risk of developing an abnormal lipid profile, type 2 diabetes and ultimately heart disease,” said Dr. Wael Al Mahmeed, Vice President of the Emirates Cardiac Society.
“Rimonabant is an important advance in the treatment of cardio-metabolic risk factors which contribute to the global risk for diabetes
Sanofil Holds little Hope for early U.S Sale of Acomplia/Zimulti(Rimonabant) 2007-08-13 05:40:24 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 analysts, said that in the wake of Sanofi’s decision in June to withdraw its application to sell Zimulti in the U.S., “we have since received confirmation from the FDA that the FDA is ready to talk to us once again.”
“The FDA has formally acknowledged that we have a strong file and has given us notice that they are absolutely ready to see us again with this file as soon as it can be completed by additional data confirming the benefit-risk profile of Zimulti in the United States,” Spek said.
During his presentation and in response to questions, Spek repeatedly said a resumption of efforts to get the FDA to approve Zimul Read more:little
Copies of diet drug Acomplia 2007-08-13 05:38:42 Copies of diet drug Acomplia (rimonabant) are being widely sold at Indian pharmacies without a prescription for as little as $3.60 for a month’s supply of the pill, according to reports from the Indian media.
A half-dozen pharmaceutical companies — including such well-regarded generic drug manufacturers as Ranbaxy and Cipla — received approval from Indian regulatory authorities in May to sell their own versions of rimonabant.
Sanofi-Aventis, developer of Acomplia / Zimulti, also received approval in May to sell its own far-more-expensive diet drug in India, but thus far has not decided whether to put in on the market. Acomplia is sold in Europe for more than $100 per month, but has not been approved for sale in the United States.
While sales of so-called “generic rimonabant” are entirely legal in India, where pharmaceutical manufacturers are allowed to produce reverse-engineered versions of drugs patented before 1995, sale of these Indian versions of rimon
Acomplia Side Effects 2007-08-12 14:04:04 Rimonabant (brand name Acomplia) has been pitched as the blockbuster weight loss drug of the decade. The company manufacturing the drug, Sanofi-Aventis believes that sales will reach $5.2 billion per year by 2010. That is a staggering amount of money.
Investors are getting swept up in the buzz, (rimonabant online),and desperate consumers are falling over themselves to get an opportunity to try the drug. However it is currently before the FDA awaiting approval - which some believe may come during early/mid 2006. Acomplia blocks cannabinoid (CB) receptors in the brain. The CB receptors are believed to play a role in controlling food consumption and dependence / habituation. People often refer to the cannabis-induced “munchies” or hunger pangs. Acomplia attempts to do the opposite.
What is an Acceptable Risk?
In the scramble for profits and quick-fix obesity solutions - no one has bothered to raise questions about the long term side effects. It is up to the health authorities to deter Read more:Effects
Acomplia Side Effects -Impact on Treatment of Addiction 2007-08-12 14:02:49 A new anti-obesity pill that has been shown to not only help lose weight and quit smoking could also be effective in helping people stop drug and alcohol addiction, scientists claim. Acomplia, or rimonabant, is an experimental drug developed by the French pharmaceutical firm Sanofi-Aventis primarily as a diet pill, but the drug works differently that most diet pills in that it blocks the brain’s reward system.
It works by blocking the connection between a pleasure-seeking activity, like smoking or overeating, and the reward “feeling” it causes in the brain. The human body contains endocannabinoids, marijuana-like substances that can stimulate the brain’s reward system.
Acomplia blocks the effect of the natural endocannabinoids by keeping them from attaching to the brain cells they usually stimulate, scientists say.
In March of this year, Acomplia gained a great deal of attention when two research studies demonstrated that it could not only help people lose weight, but quit smok Read more:Effects
, Treatment
Buy or Purchase Acomplia (Rimonabant/Zimulti) 2007-08-12 14:02:14 Buy Acomplia Rimonabant, a new class weight loss pill manufactured by French pharmaceutical Sanofi-Aventis. Rimonabant Acomplia works in a very unique way from other weight loss drugs like Xenical, hoodia or Reductil/Meridia and thus Acomplia Rimonabant (Zimulti) is most popular amongst all obese people.
Acomplia Rimonabant (Zimulti) Ingredients
In Acomplia drug, Rimonabant is the active ingredient which works on the principle of an appetite suppressant. The CB-receptors in the body are responsible for regulating food intake of the body. Usage of Acomplia (Rimonabant) basically obstructs the functioning of these CB-1 receptors, thereby decreasing your appetite. This activity in turn leads to weight loss. A combination of proper diet and regular workout regime along with Acomplia drug (Rimonabant) can pave path for an effectual weight loss.
Acomplia Rimonabant (Zimulti) Approval in Europe UK and USA by FDA and EU Union
Acomplia drug (Rimonabant) has been approved in the UK, Germany, Sw Read more:Purchase
Acomplia, New Study Finds Diet Drug Acomplia May Help Reduce Liver Damage 2007-08-12 14:00:21 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 abo Read more:Damage
, New Study
Acomplia at the same time with antidepressants -Not indicated 2007-08-12 13:59:32 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 Healthcare Products Regulatory Agency (MHRA) said on July 19th.
“Amongst these, there have been 48 reports of depression, 16 reports of suicidal thoughts and one report of self-injury,” the regulatory agency said.
The MHRA said evidence suggested one person in 10 taking Acomplia may develop psychiatric side effects, and “approximately one patient in every 100 may experience suicidal thoughts.”
The MHRA advised: “If you start to experience symptoms of depression while taking Acomplia, or if you are currently being treated with antidepressants
, consult your doctor.
“If you have had depression in
You should try rimonabant trial first 2007-08-12 13:58:50 Good info about hoodia gordonii diet, I also tried it and was suprised with the reults I got, but I will have to work out a little more to keep the status quo
I read about hoodia diet a lot and found what Oprah had to say about hoodia in the O Magazine
also when I ordered to try out I did not pay for hoodia, I recommend you do not do it either untill you see if it works for you . You can find a list of free hoodia offers here
http://www.HoodiaWeightLossTrial.com
Diet Drug Acomplia / Zimulti Dealt Blow as FDA Panel Says Keep It Off U.S. Market 2007-08-16 04:00:33 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 pr Read more:Panel
, Market
Acomplia (Rimonabant) Safety Data to Be Reviewed by Europeans Next Week 2007-08-16 04:00:09 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 li Read more:Safety
, Europeans
If You Want Acomplia (Rimonabant), You Won’t Find It Anywhere as Zimulti 2007-08-16 03:59:46 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 this Read more:Anywhere
Diet Drug Acomplia (Rimonabant) Users in Germany Get Bad News on Reimbursement 2007-08-16 03:59:19 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 th Read more:Bad News
Diet Drug Acomplia (Rimonabant) Gets Reprieve in Europe 2007-08-16 03:58:42 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 the
New European Recommendations on Diet Drug Acomplia May Be Published June 29th 2007-08-16 03:58:04 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 Europe
Sanofi Withdraws Bid to Sell Diet Drug Acomplia (Rimonabant) in United States 2007-08-16 03:57:26 The effort to get diet drug rimonabant (Acomplia / Zimulti) approved for sale in the UnitedStates
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 receptors
Sanofi: Diet Drug Acomplia Requires Indefinite Use to Keep Weight Off 2007-08-16 03:57:05 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 whil Read more:Weight
New Study Finds Diet Drug Acomplia May Help Reduce Liver Damage 2007-08-16 03:56:38 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 abo Read more:Damage
, New Study
Europeans to Decide Whether to Further Restrict Diet Drug Acomplia This Week 2007-08-15 04:24:39 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 U.S. Food and Drug Administration advisory panel to recommend that rimonabant not be sold in the United States.
EMEA regulators said that since the unanimous FDA advisory panel decision in mid-June recommending against sale of Acomplia, they have been “reviewing the available data on psychiatric events” including suicidal ideation and depression-related events.
The EMEA’s post-marketing data showed that 208 psychiatric adverse events were reported with Acomplia during the year it has been on the market, including 27 cases of suicidal ideation (thoughts of suicide).
That compared with 14 cases of suicidal ideation with diet drug Xenical si Read more:Further
, Restrict
Rimonabant Acomplia Helps With Weight Loss 2007-08-19 09:58:30 Rimonabant Acomplia Helps With Weight
Loss
Rimonabant acomplia is an anorectic anti obesity drug. It is a CB1 cannabinoid receptor antagonist. Its main avenue of effect is reduction in appetite. Obesity is now the most common nutritional disorder in western countries. Defined as a body mass index of greater than 30, it arises from the accumulation of excess fat in the body from overconsumption of fatty foods. Prevalence of obesity in the US and Europe has reached epidemic levels. Data from the World Health Organisation’s MONICA project show that in some parts of Europe over 70% of men aged 55-64 years are clinically obese or overweight (BMI >25) and almost 70% of women in this age group. One in five of all Americans is obese and one in three overweight. Furthermore, increasing rates of childhood obesity are likely to exacerbate the trend towards increasing obesity in adulthood.
Rimonabant Acomplia
Rimonabant acomplia in clinical test also found to be eff Read more:Weight Loss
FDA: Acomplia May Be ‘Approvable’ for Weight Loss, But Not Ready for Market Yet 2007-08-19 06:33:17 The U.S. Food and Drug Administration has notified Sanofi-Aventis that its much anticipated weight-loss drug Acomplia (rimonabant) appears to be “approvable,” but will not be allowed on the market until certain unspecified conditions are met.
The news that the FDA has declined to approve Acomplia came as a severe blow to Sanofi, which had told analysts only a couple of weeks ago that it was highly confident Acomplia would be okayed by the FDA this month and would be on the market in the U.S. before the end of June.
The FDA sent the French drug maker an “approvable” letter outlining conditions that Sanofi must meet to get Acomplia approved for marketing, according to an FDA spokeswoman.
“Sanofi-Aventis will continue working in close collaboration with the FDA,” the company announced on its website.
The conditions that Sanofi has to meet were not disclosed by the FDA. Spokeswoman Kathleen Quinn said: “I can confirm for you that letters were
sent but we cannot discuss any fu Read more:Weight
, Market
FDA: Acomplia Rejected as Smoking Cessation Aid 2007-08-19 06:33:00 February 2006 - The U.S. Food and Drug Administration has notified Sanofi-Aventis that its much anticipated drug Acomplia (rimonabant) is “not approvable” as an aid for smoking cessation, according to the French pharmaceutical manufacturer.
No details were immediately provided by either Sanofi or the FDA as to why Acomplia has been rejected as an aid to smoking cessation.
While Sanofi initially held high hopes for Acomplia not only as a weight-loss drug but also as a drug that could help cigarette smokers quit, it never published the results of two of its smoking-cessation studies.
Asked about this, a public relations representative of Sanofi on January 18, 2006 told us “we have a publication plan in place and publications are expected shortly.” Read more:Rejected
, Smoking
FDA Had Bad News on Acomplia for Sanofi 2007-08-19 06:32:39 When the U.S. Food and Drug Administration on Feb. 17th told Sanofi-Aventis that it was going to delay a decision on approving its much anticipated weight-loss drug Acomplia (rimonabant) until certain conditions were met, that was certainly bad news for the French pharmaceutical giant.
But until Sanofi sheds some light on the nature of those conditions, we won’t know whether we are looking at a delay of weeks, months (more likely), or even years (not out of the question).
The FDA never announces what conditions it has put forward in an “approvable” letter, leaving it up to the company to decide whether to release the information. If the conditions are relatively minor and easily resolved, the company is generally all too eager to make that clear to the public — not to mention the investment community.
But up to this point, Sanofi — which only two weeks ago was telling financial analysts and selected journalists it was “very, very confident” that FDA approval was imminent Read more:Bad News
Analyst Speculation on Acomplia Approval Seen Turning Toward 2007 2007-08-19 06:32:13 February 2006 -Frustrated securities analysts who had been led by Sanofi-Aventis management to believe U.S. FDA approval of weight-loss drug Acomplia (rimonabant) would happen this month now appear to be turning their speculation more toward 2007.
The shift from what a week ago seemed like almost universal optimism came as Friday’s announced delay of a final decision on Acomplia drove Sanofi shares down almost three percent June 20th in trading on European markets.
Sanofi disclosed on June 17th that the FDA had given it an “approvable” letter for Acomplia for weight-loss, meaning that certain conditions still have to be met before the drug will be approved for sale in the United States. The FDA at the same time rejected Acomplia outright as an aid to smoking cessation.
The FDA never discloses what conditions it sets out in “approvable” letters, and Sanofi thus far has chosen not to shed any light on whether it is now facing relatively minor hurdles or some major obstacles in Read more:Analyst
, Approval
, Toward
Diet Drug Acomplia Seen Unlikely to Get FDA Approval for ‘Metabolic Syndrome’ 2007-08-19 06:31:48 If you were hoping that diet drug rimonabant (Acomplia / Zimulti) would be approved for treatment of “metabolic syndrome” so your insurance company would be more likely to pay for your weight-loss efforts, the current thinking at the U.S. Food and Drug Administration does not appear very encouraging.
The FDA’s Metabolic and Endocrine Division has just released its long-awaited revision of its 1996 clinical guidance for development of weight-loss drugs, and it provides specific guidance for companies like Sanofi-Aventis seeking to make metabolic syndrome claims.
For the past two years, Sanofi has focused all its presentations of clinical trial data for Acomplia on “metabolic syndrome,” clearly believing insurers — notoriously reluctant to pay for diet pills — are more likely to cover a drug used to treat the cluster of conditions that increase the risk of cardiovascular disease and type 2 diabetes.
Now, the new guidance — while not yet final — suggests the FDA is takin Read more:Approval
, Syndrome
News About Future of Acomplia Seen Likely on Friday, Feb. 24th 2007-08-19 06:31:22 February 2006 - The next hard news about the future of Acomplia (rimonabant) seems likely to come this Friday
, February 24th, when Sanofi-Aventis management meets with financial analysts in Paris to discuss the company’s 2005 financial results.
Following Sanofi management’s presentation, top executives will take questions from analysts, and the toughest questions seem certain to focus on what went wrong with Sanofi’s forecasts that the U.S. Food and Drug Administration would approve Acomplia this month and the eagerly awaited weight-loss drug would be on the market by the end of June.
Securities analysts had been parroting this optimism since late last year, and when the FDA sent Sanofi an “approvable” letter last Friday rejecting Acomplia as a drug to aid smoking cessation and delaying further consideration of Acomplia for weight-loss until certain conditions are met, the company’s credibility took a severe blow.
The FDA never publicly announces the conditions it sets out Read more:Future
Sanofi Says No New Weight-Loss Trial Needed for Acomplia Approval 2007-08-19 06:31:01 February 2006 -
Sanofi-Aventis said on Feb. 22nd that the U.S. Food and Drug Administration has not requested a new trial of the drug Acomplia (rimonabant) prior to possible approval of the highly anticipated drug for use in promoting weight-loss.
As a result, Sanofi executives held open the possibility that the drug may still be on the market in the United States before the end of 2006.
“In the next few weeks, we’ll be meeting with the FDA to answer the questions that have been put to us,’’ Gerard Le Fur, who oversees the company’s research, told reporters. “We expect to introduce the drug this year.’’
Le Fur declined to elaborate on the nature of the questions the FDA has raised about Acomplia, leaving analysts only with another optimistic forecast by Sanofi — which only two weeks ago had been declaring everything on track and predicting that the FDA would approve the drug this month.
He did, however, disclose that the FDA — which rejected Sanofi’s reque Read more:Weight
, Approval
, Trial
Is There Any Factual Basis for Sanofi’s Latest Optimism on Acomplia Approval 2007-08-19 06:30:34 Is there any factual basis on which to believe the FDA will approve weight-loss drug Acomplia (rimonabant) for sale in the United States before the end of 2006, or are we once again left only with an optimistic forecast — and no supporting details — from the ever-optimistic Sanofi-Aventis management?
Well, for a man who was telling analysts less than a month ago that he was “very, very confident” on the basis of Sanofi’s “very, very close coordination” with the FDA that Acomplia would be on sale in the U.S. by summer, Sanofi executive vice president Hanspeter Spek seemed remarkably unphased by last week’s setback.
“We always report to our best knowledge,” Spek told analysts on February 24. “A launch in the second half of 2006 is the most probable launch period we can estimate as from today.”
And what is the basis for this latest forecast?
The only hard fact that Sanofi officials were willing to divulge about the nature of the issues that the FDA wants resolved b Read more:Approval
, Basis
, Optimism
Diet Drug Acomplia Now on Sale in Some Mexican Border Pharmacies 2007-08-19 06:30:10 Diet drug Acomplia (Rimonabant), which remains a considerable distance away from approval by the U.S. Food and Drug Administration, has nevertheless edged a step closer to eager American customers with news that it now can be bought in some pharmacies just across the Mexican
border.
Several readers of the Acomplia Report have emailed us this past week with news that the highly anticipated diet pill has been found in pharmacies in Los Algodones, just across the border from Yuma, AZ; Tijuana, just across the border from California; and Nuevo Laredo, just across the Texas border.
At this point, buying Acomplia in Mexican pharmacies appears to be a hit-or-miss proposition, with some pharmacies telling prospective customers they had not heard of the diet drug or had not received it yet. And we have had no reports of anyone acquiring Acomplia from a Mexican pharmacy by mail.
Mexican prices for the diet drug reported to the Acomplia Report were in the $100 range for 28 pills, making purchases Read more:Border
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