Content about Stimulants

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.

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.

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.

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.

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.

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.”

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.

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

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.

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.

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

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.