Content about topiramate

March 31, 2014

The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years.

SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years. This is the first FDA approval of a drug for migraine prevention in this age group. 

The medication is taken on a daily basis to reduce the frequency of migraine headaches.

Topamax was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004.

March 12, 2014

Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

MAPLE GROVE, Minn. — Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

Qudexy XR will be available to patients in second quarter 2014.

December 9, 2013

An experimental drug under development by Upsher-Smith Labs for epilepsy is able to reduce seizures in patients with mild to moderate side effects, according to results of a late-stage clinical trial announced Monday.

MAPLE GROVE, Minn. — An experimental drug under development by Upsher-Smith Labs for epilepsy is able to reduce seizures in patients with mild to moderate side effects, according to results of a late-stage clinical trial announced Monday.

November 18, 2013

Drug maker Upsher-Smith Labs will present data from a late-stage trial of a drug for treating epilepsy, the company said Monday.

MAPLE GROVE, Minn. – Drug maker Upsher-Smith Labs will present data from a late-stage trial of a drug for treating epilepsy, the company said Monday.

October 16, 2013

Patients taking a drug used for weight loss were able to reduce their chances of developing Type 2 diabetes, according to a new study.

MOUNTAIN VIEW, Calif. — Patients taking a drug used for weight loss were able to reduce their chances of developing Type 2 diabetes, according to a new study.

According to data from a 475-patient study published in the journal Diabetes Care, Vivus' Qsymia (phentermine and topiramate) reduced the annualized incidence rate of Type 2 diabetes by up to 78.7% in high-risk, overweight or obese patients with prediabetes or metabolic syndrome. Prediabetes is a condition in which a person has elevated blood sugar and a high risk of developing Type 2 diabetes.

August 19, 2013

The Food and Drug Administration has approved a new epilepsy drug made by Supernus Pharmaceuticals, the company said.

ROCKVILLE, Md. — The Food and Drug Administration has approved a new epilepsy drug made by Supernus Pharmaceuticals, the company said Monday.

Supernus announced the approval of Trokendi XR, a once-daily, extended-release formulation of the drug topiramate. As part of the approval, the FDA granted Supernus a waiver for some of the requirements for studies of the drug in children and a deferral for submission of other post-marketing data due in 2019, followed by clinical assessments in 2025.

July 1, 2013

A drug for treating obesity has become available through a network of about 8,000 retail pharmacies around the country, the drug's manufacturer said.

MOUNTAIN VIEW, Calif. — A drug for treating obesity has become available through a network of about 8,000 retail pharmacies around the country, the drug's manufacturer said Monday.

Vivus said the drug, Qsymia (phentermine; topiramate) extended-release capsules would be available at Costco and Walgreens stores, including Duane Reade stores. The launch is happening ahead of the previously announced mid-July launch date.

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...