Content about Phentermine

April 17, 2013
Changes to REMS to allow dispensing of Vivus obesity drug in retail

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 taking obesity drug experience improvement in cardiovascular risk factors, study finds

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.

September 19, 2012
Vivus launches obesity drug

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
FDA approves weight-loss drug

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.

January 31, 2012
FDA approves Lannett obesity drug

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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October 17, 2011
Vivus resubmits application for Qnexa

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.

August 1, 2011
Lannett receives FDA approval for generic Ionamin

The Food and Drug Administration has approved a generic version of a short-term adjunct treatment for obesity.

PHILADELPHIA — The Food and Drug Administration has approved a generic version of a short-term adjunct treatment for obesity.

Lannett said that the FDA approved its abbreviated new drug application for phentermine resin extended-release capsules in the 15-mg and 30-mg strengths. The drug, which is equivalent to UCB's Ionamin, will be sold in bariatric clinics.

July 21, 2011
Lannett receives regulatory approval for generic Adipex-P

The Food and Drug Administration has approved a drug for managing obesity made by Lannett.

PHILADELPHIA — The Food and Drug Administration has approved a drug for managing obesity made by Lannett.

Lannett announced the approval of phentermine hydrochloride capsules in the 37.5-mg strength, a generic version of Teva’s Adipex-P.

Phentermine hydrochloride capsules in the 37.5-mg strength had sales of about $8.8 million during the 12-month period ended in May, according to Wolters Kluwer.

April 7, 2011
Elite's generic Adipex-P enters market

Elite Pharmaceuticals has begun shipping an appetite suppressant for reducing weight in obese patients, the company said Thursday.

NORTHVALE, N.J. — Elite Pharmaceuticals has begun shipping an appetite suppressant for reducing weight in obese patients, the company said Thursday.

The drug maker announced the initial shipment of phentermine hydrochloride tablets in the 37.5-mg strength. The drug is a generic version of Teva’s Adipex-P.

Adipex-P and generic versions had sales of about $40 million in 2010, according to IMS Health.

The shipment was made under a collaborative agreement with precision dose and its subsidiary, TAGI Pharma.

February 18, 2011
ReportersNotebook — Chain Pharmacy, 2/28/11

SUPPLIER NEWS — Drug maker Valeant Pharmaceuticals International has acquired U.S. and Canadian rights to certain formulations of a GlaxoSmithKline drug used to treat cold sores. Valeant acquired the rights to nonophthalmic topical formulations of Zovirax (acyclovir) from GSK for $300 million through its Canadian subsidiary, Biovail Labs.



February 4, 2011
Elite granted FDA approval for generic Adipex-P

The Food and Drug Administration has approved a generic weight-loss drug made by Elite Pharmaceuticals.

NORTHVALE, N.J. — The Food and Drug Administration has approved a generic weight-loss drug made by Elite Pharmaceuticals.

Elite announced Friday the approval of phentermine hydrochloride in the 37.5-mg strength, a generic version of Teva’s Adipex-P.

Branded and generic versions of the drug had sales of around $40 million in 2010, according to Elite.

December 8, 2010
FDA panel backs Contrave

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.

October 28, 2010
FDA declines to approve Qnexa

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.

 

March 25, 2010
FDA committee to review Qnexa

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