Content about Stimulants

January 23, 2013

Novartis, Cytos terminate licensing agreement for smoking-cessation drug

Cytos Biotechnology will regain rights to an experimental vaccine against nicotine addiction that it had licensed to Novartis, Cytos said Wednesday.

SCHLIEREN, Switzerland — Cytos Biotechnology will regain rights to an experimental vaccine against nicotine addiction that it had licensed to Novartis, Cytos said Wednesday.

The company said that Novartis would discontinue the project, known as NIC002. Cytos granted Novartis a license for NIC002 in 2007, but phase-2 trial results in October 2009 indicated that the vaccine spurred the development of nicotine-specific antibodies in patients, but did not increase smoking cessation.

January 14, 2013

Pfizer announces availability of new ADHD drug

A new drug for treating attention deficit hyperactivity disorder made by Pfizer is now available, the drug maker said.

NEW YORK — A new drug for treating attention deficit hyperactivity disorder made by Pfizer is now available, the drug maker said.

Pfizer announced the availability of Quillivant XR (methylphenidate hydrochloride) extended-release oral suspension, calling it the first once-per-day, extended-release liquid formulation of methylphenidate. The Food and Drug Administration approved the drug in September 2012.

November 1, 2012

Reports: Generic extended-release drugs to get more attention from FDA

Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

NEW YORK – Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

October 19, 2012

JAMA: Director of tobacco research suggests most benefits outweigh risks when considering cessation

Smokers who have been unsuccessful to date in trying to kick the nicotine habit may be able to stop smoking by combining two smoking cessation approaches, according to a report published in the Oct. 17 issue of JAMA.

BOSTON — Smokers who have been unsuccessful to date in trying to kick the nicotine habit may be able to stop smoking by combining two smoking cessation approaches, according to a report published in the Oct. 17 issue of JAMA.

October 9, 2012

NewsBytes — Chain Pharmacy, 10/15/12

Drug maker Dr. Reddy’s Labs has launched a generic antibiotic drug, the company said. The India-based company announced the launch of amoxicillin tablets, capsules and oral suspension.

Dr. Reddy's launches antibiotics

October 5, 2012

FDA issues new guidelines for budeprion XL in the 300-mg strength

The Food and Drug Administration has reviewed new data that indicated that budeprion XL (bupropion hydrochloride extended-release tablets) in the 300-mg strength, manufactured by Impax Labs and Teva Pharmaceuticals USA, is not therapeutically equivalent to Wellbutrin XL in the 300-mg strength.

WASHINGTON — The Food and Drug Administration has reviewed new data that indicated that budeprion XL (bupropion hydrochloride extended-release tablets) in the 300-mg strength, manufactured by Impax Labs and Teva Pharmaceuticals USA, is not therapeutically equivalent to Wellbutrin XL in the 300-mg strength.

September 14, 2012

Impax, Teva settle with J&J, Alza over generic ADHD drug

Two generic drug makers have settled with a subsidiary of Johnson & Johnson and another company concerning a drug used to treat attention deficit hyperactivity disorder.

HAYWARD, Calif. — Two generic drug makers have settled with a subsidiary of Johnson & Johnson and another company concerning a drug used to treat attention deficit hyperactivity disorder.

Impax Labs and Teva Pharmaceuticals USA had settled a patent infringement suit with Janssen Pharmaceuticals and Alza over Concerta (methylphenidate hydrochloride) extended-release tablets in the 18-mg, 27-mg, 36-mg and 54-mg strengths.

September 12, 2012

Shire seeks new approval for ADHD drug

Drug maker Shire is seeking Food and Drug Administration approval for a new usage for a drug used to treat attention deficit hyperactivity disorder, the company said Wednesday.

PHILADELPHIA — Drug maker Shire is seeking Food and Drug Administration approval for a new usage for a drug used to treat attention deficit hyperactivity disorder, the company said Wednesday.

Shire announced that the FDA had accepted its regulatory approval application for Vyvanse (lisdexamfetamine dimesylate) capsules for maintenance treatment of ADHD in patients ages 6 to 17 years. There currently are no stimulants approved for maintenance treatment of the condition in that age group, Shire said, and the FDA said it would complete its review by April 2013.

August 16, 2012

Report: Nicotine replacement product sales to reach $6.2 billion worldwide by 2018

Global sales of nicotine replacement products are expected to reach $6.2 billion in 2018, following compound annual growth rates of 4.5% between now and then, GBI Research reported Wednesday.

NEW YORK — Global sales of nicotine replacement products are expected to reach $6.2 billion in 2018, following compound annual growth rates of 4.5% between now and then, GBI Research reported Wednesday.

July 18, 2012

Teva launches ADHD drug

Teva Pharmaceuticals has introduced a generic drug for treating attention deficit hyperactivity disorder, the company said.

NORTH WALES, Pa. — Teva Pharmaceuticals has introduced a generic drug for treating attention deficit hyperactivity disorder, the company said.

Teva announced the launch of methylphenidate hydrochloride extended-release capsules in the 20-mg, 30-mg and 40-mg strength. The drug, a generic version of Novartis' Ritalin, is available in 100-pill bottles.

June 25, 2012

FDA approves Actavis ADHD drug

The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Monday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Monday.

Actavis, whose parent company was recently acquired by Watson Pharmaceuticals, announced the approval of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, also known as mixed-amphetamine salts ER capsules.

April 30, 2012

Mylan to launch generic version of Nuvigil in 2016

Mylan plans to start selling a generic version of a drug for sleep disorders starting in June 2016, under a deal with Teva announced Monday.

PITTSBURGH — Mylan plans to start selling a generic version of a drug for sleep disorders starting in June 2016, under a deal with Teva announced Monday.

Mylan said it had settled with Teva over the former's generic version of Nuvigil (armodafinil) tablets, a drug used to treat sleepiness related to sleep apnea, narcolepsy and shift work disorder.

April 9, 2012

Idaho joins National Precursor Log Exchange in its fight against PSE diversion

Idaho on Monday became state No. 21 to adopt the real-time, stop-sale technology National Precursor Log Exchange in its battle against the diversion of the cough-cold ingredient pseudoephedrine to methamphetamine.

WASHINGTON — Idaho on Monday became state No. 21 to adopt the real-time, stop-sale technology National Precursor Log Exchange in its battle against the diversion of the cough-cold ingredient pseudoephedrine to methamphetamine.

April 6, 2012

Par launches generic version of Provigil

Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.

Par announced the launch of a generic version of Provigil (modafinil), used to treat such sleep disorders as narcolepsy and work shift sleep disorder.

April 5, 2012

Teva entitled to exclusivity on Provigil, FDA decides

Teva is the first company to file for a generic version of a drug to treat sleep disorders, the Food and Drug Administration has determined.

JERUSALEM — Teva is the first company to file for a generic version of a drug used to treat sleep disorders, the Food and Drug Administration has determined, though Mylan is contesting the FDA decision.

March 7, 2012

Shire to compare Vyvanse with competing drug in phase-4 trial program

Drug maker Shire will conduct two post-marketing trials to compare its treatment for attention deficit hyperactivity disorder with a competing drug, the company said Tuesday.

PHILADELPHIA — Drug maker Shire will conduct two post-marketing trials to compare its treatment for attention deficit hyperactivity disorder with a competing drug, the company said Tuesday.

Shire announced that it would start two phase-4 trials comparing its drug, Vyvanse (lisdexamfetamine dimesylate), with Alza's Concerta (methylphenidate hydrochloride).

February 22, 2012

Study: Prescription-only PSE laws have no impact on number of meth labs, meth abusers

Prescription-only pseudoephedrine regulation has no impact on the methamphetamine trade, according to a Cascade Policy Institute study on the 2005 Oregon law, which restricts access to medicines containing pseudoephedrine.

PORTLAND, Ore. — Prescription-only pseudoephedrine regulation has no impact on the methamphetamine trade, according to a Cascade Policy Institute study on the 2005 Oregon law, which restricts access to medicines containing pseudoephedrine.

February 17, 2012

Oklahoma impact study: Rx-PSE would increase health costs without reducing meth issue

According to a report prepared last month by the Economic Impact Group discerning the impact prescription-only pseudoephedrine would have on Oklahoma citizens, prescription-only PSE would result in almost 300,000 additional doctor's office visits at an estimated cost reaching $60 million; $6 million would be directly borne by consumers.

EDMOND Okla. — According to a report prepared last month by the Economic Impact Group discerning the impact prescription-only pseudoephedrine would have on Oklahoma citizens, prescription-only PSE would result in almost 300,000 additional doctor's office visits at an estimated cost reaching $60 million; $6 million would be directly borne by consumers.

February 7, 2012

FDA approves Vyvanse for adults with ADHD

The Food and Drug Administration has approved a drug made by Shire for attention deficit hyperactivity disorder, the company said Tuesday.

PHILADELPHIA — The Food and Drug Administration has approved a drug made by Shire for attention deficit hyperactivity disorder, the company said Tuesday.

Shire announced the FDA approval of Vyvanse (lisdexamfetamine dimesylate) capsules as a maintenance treatment for adults with ADHD. The drug already was approved for use in children and was approved for treating ADHD in adults in 2008.

The company said the approval was based on a clinical trial that showed more ADHD patients controlling their symptoms with Vyvanse than with placebo.

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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January 16, 2012

Workable solution to meth epidemic right under authorities' noses

That one of the latest attempts to require prescriptions for cough-cold remedies containing pseudoephedrine appears headed for failure isn't just good news for the retailers that sell those products and the people who need them, it also may encourage those trying to curb the manufacture and use of methamphetamine to focus their efforts on methods that already work, such as the National Precursor Log Exchange, also known as NPLEx, a real-time, industry-funded electronic system that tracks sales of PSE products and is active in 17 states.

WHAT IT MEANS AND WHY IT'S IMPORTANT — That one of the latest attempts to require prescriptions for cough-cold remedies containing pseudoephedrine appears headed for failure isn't just good news for the retailers that sell those products and the people who need them, it also may encourage those trying to curb the manufacture and use of methamphetamine to focus their efforts on methods that already work, such as the National Precursor Log Exchange, also known as NPLEx, a real-time, industry-funded electronic system that tracks sales of PSE products and is

January 4, 2012

FDA approves Actavis ADHD drug

The Food and Drug Administration has approved a generic version of a drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Wednesday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic version of a drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Wednesday.

December 14, 2011

Tar Heel State to renew PSE Rx-only debate in two years

North Carolina may be two years away from joining Oregon and Mississippi as the only states to classify pseudoepehdrine as a prescription-only medicine.

RALEIGH, N.C. — North Carolina may be two years away from joining Oregon and Mississippi as the only states to classify pseudoepehdrine as a prescription-only medicine.

December 7, 2011

FDA seizes ephedrine ingredients

At the request of the Food and Drug Administration, U.S. marshals on Tuesday seized raw materials imported by Infinity Marketing Group containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics that have been banned by the FDA for use in dietary supplements since 2004.

SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. marshals on Tuesday seized raw materials imported by Infinity Marketing Group containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics that have been banned by the FDA for use in dietary supplements since 2004.

The seizure took place in Rancho Dominguez, Calif. Through this action, FDA removed more than $70,000 worth of dietary supplement ingredients from the market.

October 25, 2011

Lannett gets OK for generic anti-obesity drug

Lannett has received approval from the Food and Drug Administration to market its version of an anti-obesity drug.

PHILADELPHIA — Lannett has received approval from the Food and Drug Administration to market its version of an anti-obesity drug.

The FDA approved Lannett's abbreviated new drug application for diethylpropion hydrochloride extended-release tablets in the 75-mg strength. The company expects to begin shipping the product immediately.