Content about Stimulants

December 7, 2010

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.

November 30, 2010

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

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

November 14, 2010

The Food and Drug Administration has approved an attention deficit hyperactivity disorder drug for use...

PHILADELPHIA — The Food and Drug Administration has approved an attention deficit hyperactivity disorder drug for use in adolescents.

British drug maker Shire announced Monday the approval of Vyvanse (lisdexamfetamine dimesylate) capsules for patients aged 13 to 17. The drug was already approved for children ages 6 years to 12 years and adults.

October 24, 2010

The Food and Drug Administration has approved risk evaluation and mitigation strategies for two sleep...

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.

 

 

October 7, 2010

Clinical trial data indicating an increased risk of heart attack and stroke has led to...

SILVER SPRING, Md. Clinical trial data indicating an increased risk of heart attack and stroke has led to the removal from the market of an obesity drug made by Abbott, the Food and Drug Administration said Friday.

 

The FDA said the drug maker voluntarily withdrew the drug Meridia (sibutramine) following a required post-marketing trial showing that the drug increased by 16% the risk of nonfatal heart attacks and strokes, the need for resuscitation after the heart stopped and death.

 

 

September 30, 2010

Mylan has launched a generic version of a common antidepressant, the company said Friday....

PITTSBURGH Mylan has launched a generic version of a common antidepressant, the company said Friday.

 

Mylan announced the launch of bupropion hydrochloride extended-release tablets in the 150-mg and 300-mg strengths, a once-daily treatment for depression.

 

 

The drug is a generic version of GlaxoSmithKline’s Wellbutrin XL. Various versions of the drug had sales of around $752 million during the 12-month period ended in June, according to IMS Health.

 

August 22, 2010

The industry-supported Combat Meth-amphetamine Enhancement Act, H.R. 2923, passed muster at the House Committee on...

July 20, 2010

Generic drug maker Caraco Pharmaceutical Labs has launched a generic antidepressant, Caraco said Wednesday....

DETROIT Generic drug maker Caraco Pharmaceutical Labs has launched a generic antidepressant, Caraco said Wednesday.

 

The drug maker announced the launch of bupropion hydrochloride extended-release tablets in the 150 mg and 200 mg strengths.

 

 

The drug is a generic version of GlaxoSmithKline’s Wellbutrin SR. Various versions of the drug have annual sales of $300 million, according to Caraco.

 

July 20, 2010

Actavis has received regulatory approval from the Food and Drug Administration for a generic antidepressant,...

MORRISTOWN, N.J. Actavis has received regulatory approval from the Food and Drug Administration for a generic antidepressant, the drug maker announced Wednesday.

Actavis said it immediately will begin distributing its bupropion HCl extended-release (SR) tablets in 100-mg and 200-mg strengths. The drug is the generic equivalent of GlaxoSmithKline's Wellbutrin SR. Actavis already has marketed generic Wellbutrin SR in the 150-mg strength. The drug maker received approval in March 2008.

July 8, 2010

The Food and Drug Administration on Thursday warned that Que She, marketed as an herbal...

July 6, 2010

The Food and Drug Administration has approved a drug made by Shire for treating attention...

May 16, 2010

Electronic tracking or prescription-only? That’s the question that vexed Congressional leaders last month as they...

May 3, 2010

The Food and Drug Administration has approved Mylan’s generic version of a smoking-cessation drug, Mylan...

March 29, 2010

The Federal Trade Commission’s crusade against patent settlements between branded and generic drug makers moved...

March 29, 2010

The Food and Drug Administration declined to approve a Cephalon drug as a treatment for...

March 8, 2010

Missouri has selected the National Precursor Log Exchange to serve as its statewide, real-time electronic...

March 3, 2010

The U.S. District Court for the District of Columbia has upheld a decision by the...

February 20, 2010

Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for...

January 21, 2010

Four Mississippi legislators earlier this month added the Magnolia State as one of those states...

January 10, 2010

Drug maker Cephalon and its French subsidiary sued generic drug maker Mylan in connection with...

January 5, 2010

Watson has filed an abbreviated new drug application for the generic version of a sleep...

November 19, 2009

In a nutshell, this program gives any legislative body — state or local — debating...

NEW YORK In a nutshell, this program gives any legislative body — state or local — debating around whether a prescription ought to be required in the purchase of a pseudoephedrine product one less reason to pull the trigger on that decision. And it’s a pretty big reason. Before, the argument could be made that implementing a program like NPLEx was prohibitive because of the associated cost.

October 18, 2009

There is a big danger here, and it’s a danger that has less to do...

NEW YORK There is a big danger here, and it’s a danger that has less to do with the neighborhood meth addict in search of pseudoephedrine, and more to do with appropriate access to medicines and who gets to be the gatekeeper to that access. Because not only will a prescription-only PSE restrict consumer access to a legitimate nonprescription cough-cold ingredient, but if successfully mandated by the local government, it also has the potential to limit legitimate access to just about any cost-saving OTC medicine and for just about any reason.

 

July 19, 2009

In the short term, it means pharmacists operating out of one of the 12 or...

NEW YORK In the short term, it means pharmacists operating out of one of the 12 or so pharmacies in Washington, Mo., will need to see a doctor’s prescription before filling any pseudoephedrine requests.

February 28, 2007

The most significant event that occurred during a soft 2006-2007 cough-and-cold season was the shift of the decongestant pseudoephedrine behind the counter in all 50 states. To be sure, some states still require more strict regulations on the sale of PSE, but at least now PSE is behind the counter in a legislative effort to thwart homegrown methamphetamine makers.

The most significant event that occurred during a soft 2006-2007 cough-and-cold season was the shift of the decongestant pseudoephedrine behind the counter in all 50 states. To be sure, some states still require more strict regulations on the sale of PSE, but at least now PSE is behind the counter in a legislative effort to thwart homegrown methamphetamine makers. Click below to download the PDF of ECRM Cough/Cold 2007.