Content about Euphoriants

May 17, 2013

FDA advisory committee to meet in July on opioid painkiller

A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.

SYDNEY — A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.

Australia-based QRxPharma said the FDA had determined that an advisory committee would meet on July 17 to consider a resubmitted application for Moxduo, an immediate-release formulation of the opioid painkillers morphine and oxycodone.

May 13, 2013

FDA ruling on opioid painkiller deals blow to Endo

A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

SILVER SPRING, Md. — A ruling by the Food and Drug Administration means that generic versions of an opioid painkiller made by Endo Pharmaceuticals can stay on the market, drawing criticism from the drug maker.

May 9, 2013

OxyContin patent expires, fears of abuse return

The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.

April 26, 2013

Actavis can launch generic OxyContin in January 2014 under settlement with Purdue

Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said, saying it expected to make more than $100 million in the deal between 2014 and 2015.

PARSIPPANY, N.J. — Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said Friday, saying it expected to make more than $100 million in the deal between 2014 and 2015.

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 16, 2013

Authorities worry about abuse potential as OxyContin patent expires

Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.

NEW YORK — Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.

April 16, 2013

FDA approves new labeling for OxyContin

The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said Tuesday.

The FDA announced that it approved updated labeling for reformulated OxyContin (oxycodone) extended-release tablets indicating that it has physical and chemical properties designed to deter drug abusers from crushing or dissolving the pills in order to inject or snort them.

April 9, 2013

Americans consider addiction a greater problem than chronic pain, poll shows

A majority of Americans say chronic pain ranks far below drug addiction as a major health problem, according to a new poll.

ALEXANDRIA, Va. — A majority of Americans say chronic pain ranks far below drug addiction as a major health problem, according to a new poll.

March 14, 2013

FDA to review experimental opioid drug

The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

BEDMINSTER, N.J. — The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

Australia-based QRxPharma is seeking approval for Moxduo (morphine and oxycodone), and the FDA plans to decide whether to approve the drug on Aug. 26.

March 12, 2013

State, territorial attorneys general call for anti-tampering measures in opioids

The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

NEW YORK — The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

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 23, 2013

Parents not very concerned about prescription narcotic misuse, poll finds

A new study indicated that some parents may not be sufficiently concerned about misuse of narcotic painkillers by children and teenagers.

ANN ARBOR, Mich. — A new study indicated that some parents may not be sufficiently concerned about misuse of narcotic painkillers by children and teenagers.

January 9, 2013

WEB FEATURE: FDA guidance aims to encourage abuse-deterrent painkillers

One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

SILVER SPRING, Md. — One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

December 27, 2012

Survey: DXM abuse among high school students holds steady at just under 5%

The National Institute on Drug Abuse last week released the 2012 Monitoring the Future survey, finding that 5.6% of high school seniors, 3% of eighth graders and 4.7% of tenth graders abused over-the-counter cough and cold medicines containing dextromethorphan, bringing the overall average to under 5%.

BETHESDA, Md. — The National Institute on Drug Abuse last week released the 2012 Monitoring the Future survey, finding that 5.6% of high school seniors abused over-the-counter cough and cold medicines containing dextromethorphan, a rate that has held relatively steady over the past five years. Abuse of DXM products was reported to be 3% among eighth graders and 4.7% among tenth graders, bringing the overall average to under 5%.

November 20, 2012

Reports: Canada to allow generic OxyContin approval over provincial, tribal objections

Canadian regulators have allowed the approval process for a generic opioid painkiller to go forward despite objections from provincial and other authorities, according to published reports.

NEW YORK — Canada's federal government has allowed the approval process for a generic opioid painkiller to go forward despite objections from provincial and other authorities, according to published reports.

The Associated Press reported that Canadian health minister Leona Aglukkaq turned down requests from provincial and aboriginal tribal authorities to delay approval of a generic version of Purdue Pharma's OxyContin (oxycodone). OxyContin will lose its patent protection in Canada on Sunday.

November 15, 2012

Shipments of generic version of Bontril PDM begins

Initial shipment of a generic appetite suppressant has started, the drug's manufacturer said Thursday.

NORTHVALE, N.J. — Initial shipment of a generic appetite suppressant has started, the drug's manufacturer said Thursday.

Elite Pharmaceuticals announced the initial shipment of phendimetrazine tartrate tablets in the 35-mg strength, a generic version of Valeant's Bontril PDM, under a manufacturing and supply agreement with Mikah Pharma. Actavis, recently acquired by Watson Pharmaceuticals, will distribute the drug as part of a distribution agreement between Mikah and Actavis.

November 13, 2012

Study finds fourfold increase in OxyContin prescriptions dispensed near U.S.-Canada border tunnel

The launch of a tamper-resistant formulation of a popular opioid painkiller in the United States, but not in Canada, may have influenced a spike in dispensing rate of the original at pharmacies in Canadian border cities, according to a study.

NEW YORK — The launch of a tamper-resistant formulation of a popular opioid painkiller in the United States, but not in Canada, may have influenced a spike in dispensing rate of the original at pharmacies in Canadian border cities, according to a study.

September 24, 2012

Purdue Pharma's RxPatrol provides Twitter updates on pharmacy crime

Pharmacy staff, law-enforcement officials and loss-prevention personnel can follow updates about pharmacy robberies, burglaries and potential threats in their area through Twitter updates by a drug maker that developed a program to combat pharmacy crime.

STAMFORD, Conn. — Pharmacy staff, law enforcement officials and loss-prevention personnel can follow updates about pharmacy robberies, burglaries and potential threats in their area through Twitter updates by a drug maker that developed a program to combat pharmacy crime.

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 21, 2012

FDA approves opioid addiction treatment

The Food and Drug Administration has approved a drug made by Reckitt Benckiser Pharmaceuticals for treating addiction to opioid drugs, the drug maker said.

RICHMOND, Va. — The Food and Drug Administration has approved a drug made by Reckitt Benckiser Pharmaceuticals for treating addiction to opioid drugs, the drug maker said.

Reckitt Benckiser announced the approval of Suboxone (buprenorphine and naloxone) sublingual film in the 4 mg and 12 mg strengths, used for the maintenance treatment of dependence on prescription opioid painkillers and heroin. Addiction to opioid drugs is a growing epidemic in the United States, the company said.