Content about Phenethylamines

September 13, 2011
Impax confirms patent challenge for generic Jalyn

Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.

HAYWARD, Calif. — Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.

September 13, 2011
Survey: Meth use down, thanks to services like NPLEx

Methamphetamine use is down by 50%, even as use of illicit drugs continued to climb between 2008 and 2010, according to a national survey conducted by the Substance Abuse and Mental Health Services Administration that was released last week.

ROCKVILLE, Md. — Methamphetamine use is down by 50%, even as use of illicit drugs continued to climb between 2008 and 2010, according to a national survey conducted by the Substance Abuse and Mental Health Services Administration that was released last week.

The number of current methamphetamine users decreased from 731,000 people ages 12 years and older (0.3% of the population) in 2006  to 353,000 (0.1%) in 2010.

August 1, 2011
Lannett receives FDA approval for generic Ionamin

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
Lannett receives regulatory approval for generic Adipex-P

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 seeks FDA approval for generic Vyvanse

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.

July 5, 2011
Shire files suit against Amneal, Sandoz over generic Vyvanse

Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.

June 7, 2011
Dr. Reddy's gets OK for three drugs

Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

HYDERABAD, India — Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

The drug maker said that the FDA approved donepezil hydrochloride tablets, a generic version of Pfizer and Eisai's Arciept, in the 5-mg and 10-mg strengths for the treatment of Alzheimer's disease. Both strengths will be available in 30-, 90- and 500-count bottles.

June 2, 2011
Mylan gets go-ahead for generic Effexor XR

The Food and Drug Administration has approved a generic drug for depression and anxiety made by Mylan, the drug maker said Thursday.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for depression and anxiety made by Mylan, the drug maker said Thursday.

Mylan announced the approval of venlafaxine hydrochloride extended-release capsules in the 37.5-mg, 75-mg and 150-mg strengths.

The drug, used to treat major depressive disorder and social anxiety disorder, is a generic version of Effexor XR, made by Wyeth. Mylan is launching the drug under a licensing agreement it made with Wyeth before its purchase by Pfizer.

May 25, 2011
Globe All Wellness recalls lots of Slim Xtreme product

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
Impax confirms patent challenge for generic Concerta

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.

April 7, 2011
Elite's generic Adipex-P enters market

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.

April 6, 2011
Shire files lawsuit against Watson over Adderall XR

British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

DUBLIN — British drug maker Shire has filed suit against Watson Pharmaceuticals and subsidiaries, alleging patent infringement in a case concerning a drug used to treat attention deficit hyperactivity disorder.

Shire announced Wednesday that it had filed the suit in the U.S. District Court for the Southern District of New York against Watson and several subsidiaries over their attempt to market a generic version of Adderall XR (amphetamine, dextroamphetamine mixed salts) and breach of contract.

March 18, 2011
PSE's Rx-only switch in Arkansas opens a new can of worms

The latest Arkansas proposition to control PSE sales may deliver the biggest blow to the over-the-counter accessibility argument, as it restricts sales to Arkansas residents who have a state-issued picture ID and who don’t look like they might be meth addicts. It also is no more fair or effective to have pharmacists decide who looks like a meth addict and who doesn't. Worse, the bill includes a provision that would allow the Arkansas Board of Pharmacy to color any OTC medicine with the same brush as PSE.

WHAT IT MEANS AND WHY IT’S IMPORTANT — The latest Arkansas proposition to control PSE sales may deliver the biggest blow to the over-the-counter accessibility argument, as it restricts sales to Arkansas residents who have a state-issued picture ID and who don’t look like they might be meth addicts. It also is no more fair or effective to have pharmacists decide who looks like a meth addict and who doesn't. Worse, the bill includes a provision that would allow the Arkansas Board of Pharmacy to color any OTC medicine with the same brush as PSE.

March 7, 2011
Nature's Innovation rolls out Bed Bug Patrol travel spray pen

Nature's Innovation on Saturday announced the launch of its Bed Bug Patrol travel spray pen, a nonpesticide spray for the elimination of bed bugs.

BUFORD, Ga. — Nature's Innovation on Saturday announced the launch of its Bed Bug Patrol travel spray pen, a nonpesticide spray for the elimination of bed bugs.

March 1, 2011
Express Scripts finds generic antidepressant users as adherent as brand-name counterparts

Patients who take generic antidepressants will remain as adherent as those who take brand-name drugs to treat the condition, according to a new study.

ST. LOUIS — Patients who take generic antidepressants will remain as adherent as those who take brand-name drugs to treat the condition, according to a new study.

The study, conducted by Express Scripts and published in the Journal of Managed Care Pharmacy, found patients starting generic selective serotonin reuptake inhibitors and generic selective norepinephrine reuptake inhibitors had a discontinuation rate of 44.2%, compared with 46.8% among those on brand-name SSRIs and SNRIs.

February 25, 2011
Watson seeks regulatory approval for generic Adderall XR

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
Study: Amphetamine use could pose Parkinson's disease risk

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 18, 2011
FDA wants terbutaline to carry boxed warning label

An asthma drug widely available as a generic should not be used for preventing or treating preterm labor in pregnant women, the Food and Drug Administration warned.

SILVER SPRING, Md. — An asthma drug widely available as a generic should not be used for preventing or treating preterm labor in pregnant women, the Food and Drug Administration warned.

February 8, 2011
Teva reports Q4, full-year results

Drug maker Teva on Tuesday said its North American sales during the fourth quarter ended Dec. 31 drove the drug maker's financial well-being.

JERUSALEM — Drug maker Teva on Tuesday said its North American sales during the fourth quarter ended Dec. 31 drove the drug maker's financial well-being.

February 4, 2011
Elite granted FDA approval for generic Adipex-P

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
FDA declines to approve Contrave

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 14, 2011
Kentucky introduces PSE Rx legislation

The battle for the prescription status of methamphetamine precursor/popular cough-cold ingredient pseudoephedrine now is heating up in Kentucky, just a few days following a Nevada news report that suggested the state will be considering PSE prescription-only requirements just as soon as a bill is introduced by Nevada Sen. Sheila Leslie, D-Reno.

FRANKFORT, Ky. — The battle for the prescription status of methamphetamine precursor/popular cough-cold ingredient pseudoephedrine now is heating up in Kentucky, just a few days following a Nevada news report that suggested the state will be considering PSE prescription-only requirements just as soon as a bill is introduced by Nevada Sen. Sheila Leslie, D-Reno.

December 8, 2010
FDA panel backs Contrave

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
Nonprofits urge for more means of addressing obesity epidemic

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.

December 3, 2010
Moving PSE to Rx-only in Mo. lacks fiscal sense

The forward-looking vision employed by Gov. Jay Nixon in exploring “next steps” in fighting methamphetamine abuse before even the last step has been put into place and enacted is, in a matter of speaking, extremely short-sighted. It doesn’t even make fiscal sense, because the National Precursor Log Exchange will do more to curb many of the costs associated with fighting meth addicts without conversely increasing the costs associated with fighting a cold. And truth be told, there are probably a lot more stuffy heads in Missouri than there are meth addicts.

WHAT IT MEANS AND WHY IT'S IMPORTANT — The forward-looking vision employed by Gov. Jay Nixon in exploring “next steps” in fighting methamphetamine abuse before even the last step has been put into place and enacted is, in a matter of speaking, extremely short-sighted. It doesn’t even make fiscal sense, because the National Precursor Log Exchange will do more to curb many of the costs associated with fighting meth addicts without conversely increasing the costs associated with fighting a cold.