Content about Stimulants

October 17, 2011

Generic drug maker Watson Pharmaceuticals is seeking Food and Drug Administration approval for a generic treatment for attention deficit hyperactivity disorder, the company said.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is seeking Food and Drug Administration approval for a generic treatment for attention deficit hyperactivity disorder, the company said.

Watson announced that it filed a regulatory approval application with the FDA for methylphenidate transdermal system, a patch designed to deliver the central nervous system stimulant methylphenidate over a nine-hour period. The drug is a generic version of Noven Pharmaceuticals' Daytrana.

October 11, 2011

The debate on the prescription status of pseudoephedrine in the state of Kentucky heated up last week as the deputy director of the White House Office of National Drug Control Policy Benjamin Tucker on Wednesday told Kentucky lawmakers that they should mandate PSE to Rx-only status, according to reports.

FRANKFORT, Ky. — The debate on the prescription status of pseudoephedrine in the state of Kentucky heated up last week as the deputy director of the White House Office of National Drug Control Policy Benjamin Tucker on Wednesday told Kentucky lawmakers that they should mandate PSE to Rx-only status, according to reports.

Tucker last week was the keynote speaker at the Kentucky Drug Summit, part of the Kentucky League of Cities annual convention, and headlined a panel of federal, state and local experts to examine pill mills, meth labs and prescription drug abuse.

August 1, 2011

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

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.

July 8, 2011

Watson Pharmaceuticals has filed with the Food and Drug Administration for regulatory approval for a drug to treat attention deficit hyperactivity disorder, the company said Thursday.

PARSIPPANY, N.J. — Watson Pharmaceuticals has filed with the Food and Drug Administration for regulatory approval for a drug to treat attention deficit hyperactivity disorder, the company said Thursday.

Watson said it submitted its application for lisdexamfetamine dimesylate capsules, a generic version of Shire’s Vyvanse.

June 17, 2011

The North Carolina legislature passed a real-time, stop-sale system, which allows law-abiding citizens to access medicines containing pseudoephedrine, while stopping sales that exceed the legal limit.

WASHINGTON — The North Carolina legislature passed a real-time, stop-sale system, which allows law-abiding citizens to access medicines containing pseudoephedrine, while stopping sales that exceed the legal limit.

The passage was lauded by the Consumer Healthcare Products Association.

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.

May 9, 2011

Alza Corp. is attempting to block Impax Labs from developing a generic version of Alza's attention deficit hyperactivity disorder treatment.

HAYWARD, Calif. — Alza Corp. is attempting to block Impax Labs from developing a generic version of Alza's attention deficit hyperactivity disorder treatment.

Impax confirmed that Alza filed a patent infringement suit in the U.S. District Court for the District of Delaware against the generic drug maker in connection with Concerta (methylphenidate hydrochloride) extended-release tablets in the 18-mg, 27-mg and 36-mg strengths, which is designed to treat ADHD in children ages 6 years and older, adolescents and adults up to the age of 65 years.

May 2, 2011

Watson Pharmaceuticals has launched an authorized generic version of a Johnson & Johnson drug for treating attention deficit hyperactivity disorder through a subsidiary, Watson said Monday.

PARSIPPANY, N.J. — Watson Pharmaceuticals has launched an authorized generic version of a Johnson & Johnson drug for treating attention deficit hyperactivity disorder through a subsidiary, Watson said Monday.

Watson announced the launch by Watson Labs of methylphenidate hydrochloride extended-release tablets under an agreement with J&J subsidiary Ortho-McNeil-Janssen.

April 18, 2011

Kansas on Monday officially made the move from a paper tracking system for pseudoephedrine sales to the electronic tracking capabilities afforded through the National Precursor Log Exchange, according to an Associated Press report published Monday.

TOPEKA, Kansas — Kansas on Monday officially made the move from a paper tracking system for pseudoephedrine sales to the electronic tracking capabilities afforded through the National Precursor Log Exchange, according to an Associated Press report published Monday. Kansas first announced its intent to switch over to NPLEx in March 2010.

April 7, 2011

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.

March 30, 2011

Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

The buyout offer, equal to $73 per share, includes a 29% premium over Cephalon’s stock price. Valeant noted it had made previous offers, but was “disappointed by Cephalon’s unwillingness to engage in discussions in a timely manner.”

March 25, 2011

There are three issues involving over-the-counter medicines today that have put the industry on the defensive, and all involve the question of appropriate access. Drug Store News examined each.

1. FLEXIBLE SPENDING ACCOUNTS
The issue: The Patient Protection and Affordable Care Act required that FSA participants obtain a prescription for those OTCs incorporated into their health savings agenda.

March 17, 2011

The Arkansas House on Wednesday passed a bill that would restrict the behind-the-counter sale of pseudoephedrine to pharmacists only. In other words, pharmacy technicians no longer would be allowed to sell products containing PSE.

LITTLE ROCK, Ark. — The Arkansas House on Wednesday passed a bill that would restrict the behind-the-counter sale of pseudoephedrine to pharmacists only. In other words, pharmacy technicians no longer would be allowed to sell products containing PSE.

The measure by state Sen. Percy Malone passed 60-31, according to published reports.

February 25, 2011

Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.

February 23, 2011

Use of amphetamines could increase the risk of Parkinson’s disease, according to a new study.

ST. PAUL, Minn. — Use of amphetamines could increase the risk of Parkinson’s disease, according to a new study.

February 4, 2011

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.

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.

January 13, 2011

Nevada Sen. Sheila Leslie, D-Reno, is working with Carson City district attorney Neil Rombardo on introducing a bill to require a prescription for pseudoephedrine as a tool to cut down on illicit methamphetamine production, the Las Vegas Review-Journal reported Wednesday evening.

LAS VEGAS — Nevada Sen. Sheila Leslie, D-Reno, is working with Carson City district attorney Neil Rombardo on introducing a bill to require a prescription for pseudoephedrine as a tool to cut down on illicit methamphetamine production, the Las Vegas Review-Journal reported Wednesday evening.

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 30, 2010

A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

HAYWARD, Calif. — A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

November 14, 2010

The Food and Drug Administration has approved an attention deficit hyperactivity disorder drug for use...

PHILADELPHIA — The Food and Drug Administration has approved an attention deficit hyperactivity disorder drug for use in adolescents.

British drug maker Shire announced Monday the approval of Vyvanse (lisdexamfetamine dimesylate) capsules for patients aged 13 to 17. The drug was already approved for children ages 6 years to 12 years and adults.

October 24, 2010

The Food and Drug Administration has approved risk evaluation and mitigation strategies for two sleep...

FRAZER, Pa. The Food and Drug Administration has approved risk evaluation and mitigation strategies for two sleep disorder drugs made by Cephalon, the drug maker said.

 

Cephalon announced that the FDA approved the REMS for Nuvigil (armodafinil) and Provigil (modafinil), both used to improve wakefulness in patients with sleep apnea, narcolepsy or shift work disorder.

 

 

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.