Content about Topiramate

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 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.

January 15, 2013

A maker of drugs for epilepsy has appointed a new executive.

ROCKVILLE, Md. — A maker of drugs for epilepsy has appointed a new executive.

Supernus Pharmaceuticals announced the appointment of Victor Vaughn as SVP sales, a position in which he will be responsible for leading all the company's sales activities.

October 9, 2012

The Food and Drug Administration has approved a drug made by Acton Pharmaceuticals for asthma, the company said.

SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Acton Pharmaceuticals for asthma, the company said. The drug maker announced the approval of Aerospan (flunisolide HFA) inhalation aerosol as a maintenance treatment for asthma in patients ages 6 years and older. The drug maker plans to launch the drug in early 2013.

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.

August 14, 2012

Upsher-Smith Labs has finalized its purchase of a British company that makes drugs for central nervous system and inflammatory disorders, the former said Tuesday.

MAPLE GROVE, Minn. — Upsher-Smith Labs has finalized its purchase of a British company that makes drugs for central nervous system and inflammatory disorders, the former said Tuesday.

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.

June 26, 2012

The Food and Drug Administration has given tentative approval to Supernus Pharmaceuticals for a drug to treat epilepsy, the company said Tuesday.

ROCKVILLE, Md. — The Food and Drug Administration has given tentative approval to Supernus Pharmaceuticals for a drug to treat epilepsy, the company said Tuesday.

Supernus announced the tentative approval was given to Trokendi XR (topiramate), a once-daily treatment for the seizure disorder. The company said final approval was conditioned on resolution of market exclusivity issues concerning certain pediatric populations.

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.

October 17, 2011

Vivus has reapplied to the Food and Drug Administration for approval of a drug to treat obesity, the company said Monday.

MOUNTAIN VIEW, Calif. — Vivus has reapplied to the Food and Drug Administration for approval of a drug to treat obesity, the company said Monday.

Vivus said it sent in its regulatory approval application for Qnexa (phentermine and topiramate), a drug designed to treat obese and overweight patients by inducing and maintaining weight loss.

The company originally sought approval for the drug in October 2010, though the FDA declined to approve it.

March 4, 2011

Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

SILVER SPRING, Md. — Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

The FDA said Friday that the drug topiramate could increase the risk for such birth defects as cleft palate and cleft lip when used by expectant mothers. Johnson & Johnson markets the drug under the name Topamax, and it is available in generic form.

January 5, 2011

Supplier News — The Food and Drug Administration has approved a generic drug for hypertension made by Mylan. Mylan announced the approval of nifedipine extended-release tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Bayer’s Adalat CC. Nifedipine tablets had sales of around $82 million during the 12-month period ended June 2010, according to IMS Health.



 

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.

November 8, 2010

Drug maker Upsher-Smith Labs will add an extension study to its late-stage clinical trial of...

MAPLE GROVE, Minn. Drug maker Upsher-Smith Labs will add an extension study to its late-stage clinical trial of a drug for treating epilepsy, the company said Tuesday.

 

Upsher-Smith announced an additional study for patients who completed the phase-3 “Prevail” trial of the drug USL255 (topiramate extended-release). The drug is designed to provide a once-daily dosage for adults with the disease.

 

 

October 28, 2010

Vivus found itself foiled in its efforts to market a drug for obesity as the...

MOUNTAIN VIEW, Calif. Vivus found itself foiled in its efforts to market a drug for obesity as the Food and Drug Administration turned down its regulatory approval application.

 

July 18, 2010

Research and development pipelines are flowing with a record number of drugs for treating diabetes...

July 15, 2010

The possibility of a new drug for treating obesity suffered a setback Thursday as a...

June 10, 2010

Health insurer Blue Cross Blue Shield of Texas alleged that drug maker Pfizer marketed its...

May 23, 2010

Two subsidiaries of Johnson & Johnson will pay more than $81 million to the federal...

March 25, 2010

A Food and Drug Administration committee will review a drug by Vivus for obesity, the...

March 9, 2010

The market for diabetes drugs will be worth $37 billion by 2018, up from $20...