Content about Anti-obesity medication

April 17, 2013

The Food and Drug Administration has approved a modification to a program added to the labeling of an obesity drug to ensure patient safety.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has approved a modification to a program added to the labeling of an obesity drug to ensure patient safety.

Vivus announced that the FDA had approved changes to the risk evaluation and mitigatin strategy for Qsymia (phentermine and topiramate) extended-release capsules. The amendment to the REMS allows the drug to be dispensed through certified retail pharmacies in addition to the existing network of mail-order pharmacies.

February 15, 2013

U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla.

SILVER SPRING, Md. — U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active pharmaceutical ingredient.

February 1, 2013

Patients who take a drug for losing weight may experience improvement in multiple cardiovascular disease risk factors, according to a new study.

MOUNTAIN VIEW, Calif. — Patients who take a drug for losing weight may experience improvement in multiple cardiovascular disease risk factors, according to a new study.

November 28, 2012

Price inflation for the most commonly used branded drugs has been more than six times that of overall inflation for consumer goods since September 2011, according to a new report by pharmacy benefit manager Express Scripts.

ST. LOUIS — Price inflation for the most commonly used branded drugs has been more than six times that of overall inflation for consumer goods since September 2011, according to a new report by pharmacy benefit manager Express Scripts.

October 15, 2012

The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

SILVER SPRING, M.D. — The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

According to several published reports, FDA commissioner Margaret Hamburg recently told a group of scientific advisers that the agency is considering allowing makers of drugs having a societal benefit to conduct faster clinical trials with a smaller group of patients than is now required.

September 19, 2012

Drug maker Vivus has released what it called the first new drug in 13 years for chronic weight management in adults.

MOUNTAIN VIEW, Calif. — Drug maker Vivus has released what it called the first new drug in 13 years for chronic weight management in adults.

The company announced the availability of Qsymia (phentermine and topiramate) extended-release capsules, which it is formally introducing to medical professionals this week at the Obesity Society's annual scientific meeting in San Antonio.

July 18, 2012

The Food and Drug Administration has approved a new weight-loss drug made by Vivus, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new weight-loss drug made by Vivus, the agency said.

The FDA announced the approval of Qsymia (phentermine and topiramate) extended-release, designed for use by overweight and obese adults alongside a reduced-calorie diet and exercise for chronic weight management. The drug's original brand name was Qnexa.

July 9, 2012

GlaxoSmithKline on Monday issued an email blast to registrants of its MyAlli.com site that Alli will be making its way back to store shelves later this month.

PITTSBURGH — GlaxoSmithKline on Monday issued an email blast to registrants of its MyAlli.com site that Alli will be making its way back to store shelves later this month.

June 27, 2012

The Food and Drug Administration has approved a new treatment for obesity in adults, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for obesity in adults, the agency said Wednesday.

The FDA announced the approval of Arena Pharmaceuticals' Belviq (lorcaserin hydrochloride), designed for use alongside reduced-calorie diets and exercise, for chronic weight management. Eisai will distribute the drug.

February 23, 2012

A panel of experts at the Food and Drug Administration has recommended approval for an obesity drug that so far had not met much success at the agency.

MOUNTAIN VIEW, Calif. — A panel of experts at the Food and Drug Administration has recommended approval for an obesity drug that so far had not met much success at the agency.

Vivus announced Wednesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving Qnexa (phentermine and topiramate) for obesity in adults. The FDA is not bound by advisory committee votes when it decides whether or not to approve a drug, but usually follows them.

January 31, 2012

The Food and Drug Administration has approved a generic drug for obesity made by Lannett, the drug maker said Tuesday.

PHILADELPHIA — The Food and Drug Administration has approved a generic drug for obesity made by Lannett, the drug maker said Tuesday.

Lannett announced the approval of phentermine hydrochloride capsules in the 15-mg strength.

Various versions of the drug had sales of $11 million at average wholesale price in 2011, according to Wolters Kluwer.


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December 7, 2011

Obese diabetes patients could experience weight loss when taking Vivus' anti-obesity drug, according to an oral presentation at the International Diabetes Federation's World Diabetes Congress in Dubai.

MOUNTAIN VIEW, Calif. — Obese diabetes patients could experience weight loss when taking Vivus' anti-obesity drug, according to an oral presentation at the International Diabetes Federation's World Diabetes Congress in Dubai.

October 25, 2011

Lannett has received approval from the Food and Drug Administration to market its version of an anti-obesity drug.

PHILADELPHIA — Lannett has received approval from the Food and Drug Administration to market its version of an anti-obesity drug.

The FDA approved Lannett's abbreviated new drug application for diethylpropion hydrochloride extended-release tablets in the 75-mg strength. The company expects to begin shipping the product immediately.

September 22, 2011

Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.

SAN DIEGO — Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.

August 5, 2011

Amylin Pharmaceuticals and Takeda Pharmaceutical have halted development of a treatment for obesity in mid-stage clinical trials, the two companies said.

SAN DIEGO — Amylin Pharmaceuticals and Takeda Pharmaceutical have halted development of a treatment for obesity in mid-stage clinical trials, the two companies said.

The companies said the decision to discontinue development of a therapy that combines pramlintide and metreleptin was based on "a commercial reassessment of the pramlintide/metreleptin program … [that] took into account a revised development plan, as well as evolving dynamics within he obesity therapeutic area."

June 27, 2011

Use of a drug for Type 2 diabetes made by Eli Lilly and Amylin Pharmaceuticals may lower patients’ risk of heart failure, according to a new study.

SAN DIEGO — Use of a drug for Type 2 diabetes made by Eli Lilly and Amylin Pharmaceuticals may lower patients’ risk of heart failure, according to a new study.

The study of more than 778,000 patients taking the injected drug Byetta (exenatide) found that adding the drug to a pre-existing diabetes regimen, especially if that regimen included insulin, was associated with reduced likelihood of heart failure. Results were presented Saturday at the 71st Scientific Sessions of the American Diabetes Association in San Diego.

May 25, 2011

Globe All Wellness on Tuesday recalled all lots of its Slim Xtreme herbal slimming capsule upon learning that the Food and Drug Administration determined the product contains the undeclared drug ingredient sibutramine.

HOLLYWOOD, Fla. — Globe All Wellness on Tuesday recalled all lots of its Slim Xtreme herbal slimming capsule upon learning that the Food and Drug Administration determined the product contains the undeclared drug ingredient sibutramine.

Sibutramine was the active ingredient in the prescription weight-loss drug Meridia, which had been pulled off the U.S. market due to increased risk of cardiovascular events or stroke.

March 16, 2011

Amylin Pharmaceuticals and Takeda Pharmaceutical have suspended a mid-stage trial of an obesity drug over safety concerns, the two said Wednesday.

SAN DIEGO — Amylin Pharmaceuticals and Takeda Pharmaceutical have suspended a mid-stage trial of an obesity drug over safety concerns, the two said Wednesday.

The drug makers stopped the phase-2 trial of a combination of pramlintide and metreleptin due to problems that arose in two patients related to metreleptin. Amylin said the decision to suspend the trial did not affect its investigations of metreleptin as a treatment of diabetes and hypertriglyceridemia in patients with lipodystrophy.

February 1, 2011

The Food and Drug Administration has turned down an application for an anti-obesity drug.

SAN DIEGO — The Food and Drug Administration has turned down an application for an anti-obesity drug.

Orexigen Therapeutics and Takeda Pharmaceutical said Tuesday that the FDA had issued a complete response letter for their application for Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets.

December 8, 2010

A Food and Drug Administration advisory committee has recommended approval for an investigational diet pill.

SAN DIEGO — A Food and Drug Administration advisory committee has recommended approval for an investigational diet pill.

Orexigen Therapeutics and Takeda Pharmaceutical announced Tuesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-7 that clinical trial data demonstrated that the benefits of the drug Contrave (naltrexone and bupropion) outweighed its risk and supported approval. The committee also voted 11-8 to recommend a study to examine Contrave’s effect on risk for cardiac disease.

December 7, 2010

As a Food and Drug Administration advisory committee convenes to decide whether or not to approve a new drug for treating obesity, two nonprofit groups centered on the epidemic said more means of addressing it are needed.

SILVER SPRING, Md. — As a Food and Drug Administration advisory committee convenes to decide whether or not to approve a new drug for treating obesity, two nonprofit groups centered on the epidemic said more means of addressing it are needed.

October 7, 2010

Clinical trial data indicating an increased risk of heart attack and stroke has led to...

SILVER SPRING, Md. Clinical trial data indicating an increased risk of heart attack and stroke has led to the removal from the market of an obesity drug made by Abbott, the Food and Drug Administration said Friday.

 

The FDA said the drug maker voluntarily withdrew the drug Meridia (sibutramine) following a required post-marketing trial showing that the drug increased by 16% the risk of nonfatal heart attacks and strokes, the need for resuscitation after the heart stopped and death.

 

 

September 16, 2010

An advisory committee of the Food and Drug Administration has given a thumbs-down to a...

SAN DIEGO An advisory committee of the Food and Drug Administration has given a thumbs-down to a drug for treating obesity.

 

Eisai and Arena Pharmaceuticals said Thursday that the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 9-5 to recommend against approval of the drug lorcaserin, saying clinical trial data did not adequately show that its benefits would outweigh its risks.

 

 

September 1, 2010

The National Center for Complementary and Alternative Medicine's small-business technology transfer program, part of the...

EMERYVILLE, Calif. The National Center for Complementary and Alternative Medicine's small-business technology transfer program, part of the National Institutes of Health, has given a researcher and a drug maker a grant to develop drugs for obesity and metabolic syndrome in women.

 

July 8, 2010

The Food and Drug Administration on Thursday warned that Que She, marketed as an herbal...