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Belviq 9 articles

FDA approves new diet pill Contrave

A new prescription diet pill has been given clearance by the Food and Drug Administration (FDA) for marketing in the United States. Contrave, made by Orexigen Therapeutics, is a combination of bupropion, an antidepressant that is also used for smoking cessation, and naltrexone, a drug used to treat drug and alcohol dependence. Contrave is approved for overweight or obese patients with a body mass index (BMI) of 30 or higher, as well as people with a BMI of 27 or higher with at least one other health issue such as diabetes. Patients treated with Contrave lost an average of 4.2 ... Read More

FDA delays decision on diet pill based on heart risk evaluation

The Food and Drug Administration (FDA) has delayed its decision by three months on the new diet pill contrave in order to reach an agreement with drug company Orexigen Therapeutics regarding post-marketing obligations related to the evaluation of cardiovascular risks associated with the drug. Orexigen and the FDA are currently in talks about the package insert and other post-marketing requirements. The FDA had rejected the drug in 2011, saying it needed more studies to put to rest concerns about heart risks. Orexigen came back nearly three years later with an analysis involving 8,900 patients showing patients taking contrave did not ... Read More

Drug company Orexigen conducts tests on experimental diet pill Contrave

Interim analysis of Orexigen Therapeutics’ experimental weight loss drug Contrave showed successful results, setting the stage for possible marketing approval by United States drug regulators by June 2014. The Food and Drug Administration (FDA) rejected Orexigen’s bid for approval in February 2011, saying it needed more data from a large-scale study on the long-term effects the obesity medication has on the heart. Contrave is a combination of two already approved medications – bupropion, which is the active ingredient in the antidepressant Wellbutrin, and the anti-addiction drug naltrexone. Contrave is designed to influence the hypothalamus in in order to decrease food ... Read More

European regulators skeptical about new prescription diet pills

European drug regulators are leery about approving the new weight loss drug Belviq because of safety concerns, including heart valve problems and psychiatric side effects in patients, and tumors observed during studies on lab rats. Belviq is currently under review by an advisory panel for the European Medicines Agency (EMA), which is expected to make a recommendation for the EMA by March whether to approve the drug. Arena Pharmaceuticals, the drug’s maker, has been working with the agency to answer questions and clear up any matters that stand in the way of approval. But its chances may be slim. The ... Read More

Drug company wants to speed review process for new diet drug Contrave

Orexigen Therapeutics Inc. is hoping the Food and Drug Administration (FDA) will grant its request to speed up the review process for its obesity drug Contrave. The agency rejected the weight loss drug in February 2011, saying it needed data from a large-scale study on the long-term cardiovascular effects associated with the medication before approval would be granted. Contrave is a combination of two medications already approved by the FDA – bupropion, which is the active ingredient in the antidepressant Wellbutrin, and the anti-addiction drug naltrexone. Contrave is designed to influence the hypothalamus in order to decrease food intake over ... Read More

New diet drug Qsymia may be rejected by European drug regulators

Qsymia, first diet drug to be approved in 13 years by the U.S. Food and Drug Administration (FDA), may not get clearance from the European Medicines Agency because of the potential for heart problems. A European Union advisory panel is expected to rule on the weight loss treatment sometime next month, but the drug’s maker Vivus Inc. says it has been getting some cold vibes from the group. If rejected, Vivus says it will file a new marketing application or appeal the decision. Vivus wants to market Qsymia in Europe under the name Qsiva. This summer, the FDA approved Qsymia ... Read More

New diet drug Qsymia now available by prescription

The much anticipated diet drug Qsymia is officially on the market. Qsymia, made by Vivus, is one of two new weight loss drugs approved earlier this year by the Food and Drug Administration (FDA), becoming the first diet pills cleared by the FDA in more than 13 years. Unlike other drugs for weight loss, Qsymia, and new rival Belviq, are considered “life-long” treatments for obesity and should be used along with a diet and exercise program. Though both help users lose weight, they work in entirely different ways. Belviq contains the active ingredient lorcaserin, which works by activating a part ... Read More

FDA approves two life-long prescription diet drugs

Two new medications are the first in 13 years to be approved by the Food and Drug Administration (FDA) for long-term weight management. Marketed as Belviq and Qsymia, the prescription drugs are designed to be taken for the rest of a person’s life – along with a healthy lifestyle – for obese and overweight people who have been unsuccessful in getting their weight under control with diet and exercise. More than a third of adults in the United States are obese, and obesity contributes to a number of health conditions including high blood pressure, type 2 diabetes, and high cholesterol. “For ... Read More

FDA approves Belviq, first weight loss drug in more than a decade

A new prescription weight-loss pill has been approved by the Food and Drug Administration (FDA), making it the first diet pill to hit the U.S. market in more than a decade. Arena Pharmaceuticals Belviq (lorcasserin) was deemed safe enough to get a nod by drug regulators, though the agency says studies showed only modest weight loss in clinical trials. Belviq was approved for adults who are obese or overweight with at least one medical complication such as diabetes or high cholesterol. The drug should be used with a healthy diet and exercise. The FDA first rejected Belviq in 2010 after ... Read More