Content about Amphetamines

May 21, 2013

Court upholds Mylan's patents on COPD drug

A federal appellate court has ruled in favor of Mylan in a case involving a drug for chronic obstructive pulmonary disease, the drug maker said.

PITTSBURGH — A federal appellate court has ruled in favor of Mylan in a case involving a drug for chronic obstructive pulmonary disease, the drug maker said Tuesday.

Mylan said that the Court of Appeals for the Federal Circuit had reversed a lower court's decision invalidating five patents held by subsidiary Mylan Specialty for Perforomist (formoterol fumarate) in a case filed in 2007 against Dainippon Sumitomo Pharma subsidiary Sunovion Pharmaceuticals over the drug Brovana (arformoterol tartrate).

April 26, 2013

Rogue Internet pharmacies should be primary focus in efforts to secure supply chain

A House Subcommittee on Health hearing Thursday focused on efforts to strengthen the country's pharmaceutical supply chain, and particularly on draft legislation meant to accomplish that.

While often touted as the safest in the world, the U.S. drug supply chain remains vulnerable to counterfeit, adulterated and stolen medications. Given the potentially dangerous risks of using such medicines, it is imperative that they be kept out.

A House Subcommittee on Health hearing Thursday focused on efforts to strengthen the country's pharmaceutical supply chain, and particularly on draft legislation meant to accomplish that.

April 24, 2013

Parents often complicit in teens' prescription drug abuse, study finds

A dramatic jump in the rates of misuse of prescription stimulants over the past four years is linked to lax attitudes on the part of parents, according to a new study, though misuse and abuse of prescription opioids has remained flat.

NEW YORK — A dramatic jump in the rates of misuse of prescription stimulants over the past four years is linked to lax attitudes on the part of parents, according to a new study, though misuse and abuse of prescription opioids has remained flat.

April 10, 2013

Cardinal Health Foundation helps combat Rx drug abuse with Generation Rx University

With the growing concern of the abuse of prescription stimulants like Adderall on college campuses, the Cardinal Health Foundation and the Ohio State University College of Pharmacy introduced Generation Rx University, the fourth in a series of interactive toolkits designed to help reduce the abuse of prescription drugs.

DUBLIN, Ohio — With the growing concern of the abuse of prescription stimulants like Adderall on college campuses, the Cardinal Health Foundation and the Ohio State University College of Pharmacy on Wednesday introduced Generation Rx University, the fourth in a series of interactive toolkits designed to help reduce the abuse of prescription drugs.

February 15, 2013

FDA approves Teva ADHD drug

The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Teva Pharmaceutical Industries, the Israeli generic drug maker said.

JERUSALEM — The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Teva Pharmaceutical Industries, the Israeli generic drug maker said.

February 11, 2013

Shire to pay Impax $48 million in authorized generic Adderall XR case

Generic drug maker Impax Labs has settled with Shire Labs over an authorized generic version of a Shire drug for treating attention deficit hyperactivity disorder, Impax said.

HAYWARD, Calif. — Generic drug maker Impax Labs has settled with Shire Labs over an authorized generic version of a Shire drug for treating attention deficit hyperactivity disorder, Impax said.

January 15, 2013

Supernus appoints Victor Vaughn as SVP sales

A maker of drugs for epilepsy has appointed a new executive.

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.

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.

July 16, 2012

Rx drug abuse rises in high school students

Several policy-makers and companies have sought ways to confront the problem of prescription drug abuse. Last month, New York Gov. Andrew Cuomo announced a plan — calling it the first in the country — to create an all- electronic registry that would enable doctors, pharmacists and law enforcement to track controlled substances to prevent excessive prescription and refill requests.

News broke last month that officials in the South American nation of Uruguay were planning to possibly legalize marijuana. Meanwhile, activists in Colorado have sought to legalize the drug in that state, while Chicago’s city council decriminalized possession of small amounts of marijuana and reduced the penalty to a ticket. 

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.

June 21, 2012

Divergent pathways in switch paradigm

While the picture of a new Rx-to-OTC switch paradigm is being painted with a broad stroke brush, already there are two divergent pathways emerging around what that new paradigm landscape might look like.  

OTC manufacturers have been framing the new paradigm within the existing two-drug-class system, suggesting that the diagnostic tools that already are available in the marketplace significantly could help expand which medicines are considered appropriate in the OTC space. 

Retail pharmacists, on the other hand, are advocating for the creation of a third class of drugs. 

June 21, 2012

PSE restriction, OTCS in FSAs  remain focus of legislation

Currently there are two overarching legislative issues that either threaten to place greater restrictions on certain over-the-counter medicines or fail to restore access to an OTC benefit that once played a significant role in helping develop interest in the flexible spending account plans available today. 

May 30, 2012

FDA warns consumers, healthcare professionals about fake Adderall

A counterfeit version of a Teva Pharmaceutical Industries attention deficit hyperactivity disorder and narcolepsy drug is circulating online, regulators warned Tuesday.

SILVER SPRING, Md. — A counterfeit version of a Teva Pharmaceutical Industries attention deficit hyperactivity disorder and narcolepsy drug is circulating online, regulators warned Tuesday.

The Food and Drug Administration issued a statement warning consumers and healthcare professionals that a fake versions of Adderall (dextroamphetamine and amphetamine) tablets in the 30-mg strength are being sold on the Internet.

May 3, 2012

CHPA releases update on latest PSE legislation

The Consumer Healthcare Products Association on Thursday provided an update around pseudoephedrine legislation in its "CHPA Executive Newsletter," which is published monthly.

WASHINGTON — The Consumer Healthcare Products Association on Thursday provided an update around pseudoephedrine legislation in its "CHPA Executive Newsletter," which is published monthly.

A bill supporting the use of the National Precursor Log Exchange is scheduled to be heard by Colorado's Senate Judiciary Committee on May 4 following a House vote of 50-14 to pass the bill.

In Hawaii, a bill to adopt NPLEx is awaiting Gov. Neil Abercrombie's signature. If signed, Hawaii would become the 22nd NPLEx state.

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.

March 13, 2012

West Virginia adopts NPLEx system

West Virginia has become the 19th state to require pharmacists and other retailers to be connected through the National Precursor Log Exchange system with the passage of legislation that requires real-time, stop-sale technology to enable the state's pharmacists to block illegal pseudoephedrine purchases right at the point of sale and provide law enforcement with up-to-the minute criminal data.

WASHINGTON — West Virginia has become the 19th state to require pharmacists and other retailers to be connected through the National Precursor Log Exchange system with the passage of legislation that requires real-time, stop-sale technology to enable the state's pharmacists to block illegal pseudoephedrine purchases right at the point of sale and provide law enforcement with up-to-the minute criminal data.

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 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 13, 2012

California Senate committee tables PSE Rx-only bill

The California State Senate Health Committee on Wednesday tabled a bill that would require a prescription for the purchase of a pseudoephedrine product, exempting children's liquid formulations.

SACRAMENTO, Calif. — The California State Senate Health Committee on Wednesday tabled a bill that would require a prescription for the purchase of a pseudoephedrine product, exempting children's liquid formulations.

The bill initially failed to pass the committee by a vote of 2-2 with five no-votes. Subsequently, the committee placed the bill up for reconsideration by a vote of 7-0 with two no-votes. No subsequent hearing date has been posted the Senate's website.

December 15, 2011

DXM abuse down among high school seniors; overall Rx and Vicodin abuse up

Approximately 5.3% of high school seniors abused over-the-counter cough-cold medicines in the past month, according to the latest "Monitoring the Future" survey released Wednesday by the National Institute on Drug Abuse.

WASHINGTON — Approximately 5.3% of high school seniors abused over-the-counter cough-cold medicines in the past month, according to the latest "Monitoring the Future" survey released Wednesday by the National Institute on Drug Abuse. That's down from 6.6% of high school seniors who claimed to have recently abused cough-cold medicines last year.

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.