Content about Topiramate

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.

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.

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.

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.

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.

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.

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.