Content about Phenethylamines

May 1, 2013

Teva Pharmaceutical Industries has launched a generic inhaler used to treat bronchospasm, the company said.

NORTH WALES, Pa. — Teva Pharmaceutical Industries has launched a generic inhaler used to treat bronchospasm, the company said.

Teva announced the introduction of levalbuterol inhalation solution. The product is a generic version of Sunovion's Xopenex and is available in the 0.31 mg, 0.63 mg and 1.25 mg strengths.

Various versions of the drug had sales of $438.8 million in 2012, according to IMS Health.

March 18, 2013

The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

PITTSBURGH — The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

Mylan announced the approval of levalbuterol inhalation solution in the 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL strengths. The company has begun shipping the product.

The drug is a generic version of Sunovion's Xopenex inhalation solution, which is used to treat bronchospasm in patients ages 6 years and older with reversible obstructive airway disease.

February 15, 2013

U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla.

SILVER SPRING, Md. — U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active pharmaceutical ingredient.

January 8, 2013

The Food and Drug Administration on Tuesday advised consumers not to purchase or use “MAXILOSS Weight Advanced” — a product promoted and sold for weight loss on various web sites, including DreamLifeWeightLoss.com, and in some retail stores.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday advised consumers not to purchase or use “MAXILOSS Weight Advanced” — a product promoted and sold for weight loss on various web sites, including DreamLifeWeightLoss.com, and in some retail stores.

January 3, 2013

An inhaler for patients with bronchospasm that includes a dose counter has become available from Teva Respiratory, the company said Thursday.

NORTH WALES, Pa. — An inhaler for patients with bronchospasm that includes a dose counter has become available from Teva Respiratory, the company said Thursday.

The company, which is the branded respiratory division of Israeli drug maker Teva Pharmaceutical Industries, announced the available of ProAir HFA (i.e., albuterol sulfate), for patients aged 4 and older to prevent and treat bronchospasm with reversible obstructive airway disease and prevent exercise-induced bronchospasm. The inhaler received Food and Drug Administration approval in March 2012.

September 7, 2012

Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.

ALLEGAN, Mich. — Perrigo is seeking regulatory approval for what it called the first generic version of a drug for treating bronchospasm.

August 20, 2012

Prasco Labs is distributing an authorized generic version of a respiratory drug under an agreement with the branded drug's manufacturer.

CINCINNATI, Ohio — Prasco Labs is distributing an authorized generic version of a respiratory drug under an agreement with the branded drug's manufacturer.

June 28, 2012

The Food and Drug Administration has approved a new drug for treating overactive bladder made by Astellas Pharma, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating overactive bladder made by Astellas Pharma, the agency said Thursday.

The FDA announced the approval of Myrbetriq (mirabegron), which works by relaxing the bladder muscle while the organ is filling. In patients with overactive bladder, the muscle can't be controlled, squeezes too often or squeezes without warning. Symptoms of overactive bladder include the need to urinate too often, the need to urinate immediately and incontinence. The condition affects about 33 million Americans.

June 25, 2012

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

Taken together, asthma and chronic obstructive pulmonary disease — which includes chronic bronchitis and emphysema — affect nearly 50 million Americans, or about 15% of the total U.S. population, according to statistics from such organizations as the Centers for Disease Control and Prevention.

Taken together, asthma and chronic obstructive pulmonary disease — which includes chronic bronchitis and emphysema — affect nearly 50 million Americans, or about 15% of the total U.S. population, according to statistics from such organizations as the Centers for Disease Control and Prevention. And combined, the two diseases cause more than 100,000 deaths per year. Fortunately, however, there is a wide range of treatments available for both, many of which work for both diseases.


May 30, 2012

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 29, 2012

A unit of generic drug maker Mylan has settled with Sunovion Pharmaceuticals over a drug used to treat chronic obstructive pulmonary disease and asthma.

PITTSBURGH — A unit of generic drug maker Mylan has settled with Sunovion Pharmaceuticals over a drug used to treat chronic obstructive pulmonary disease and asthma.

Mylan announced Tuesday that it had reached a settlement in a patent litigation suit that Sunovion, which used to operate under the name Sepracor, had filed against Dey Pharma, now known as Mylan Specialty, concerning the drug Xopenex (levalbuterol hydrochloride).

March 20, 2012

Novartis has launched a new treatment for chronic obstructive pulmonary disease, the drug maker said Monday.

EAST HANOVER, N.J. — Novartis has launched a new treatment for chronic obstructive pulmonary disease, the drug maker said Monday.

Novartis Pharmaceuticals, the U.S. division of the Swiss drug manufacturer, announced the launch of Arcapta Neohaler (indacaterol inhalation powder) in the 75-mcg strength. The Food and Drug Administration approved the drug last July.

March 9, 2012

The Food and Drug Administration has approved a version of a drug made by Teva that includes a dose counter, the drug maker said.

NORTH WALES, Pa. — The Food and Drug Administration has approved a version of a drug made by Teva that includes a dose counter, the drug maker said.

Teva announced the approval of the inhaled drug ProAir HFA (albuterol sulfate) with a dose counter for treating bronchospasm with reversible obstructive airway disease and preventing exercise-induced bronchospasm in patients ages 4 years and older. The dose counter is designed to help patients and caregivers keep track of the number of doses in the canister.

March 7, 2012

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

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

One of the main plotlines of the big story called the drug industry over the past several years has been the patent cliff, the steady loss of patent protection on blockbuster primary care drugs and subsequent generic competition that has forced many drug companies to find new revenue streams.

One of the main plotlines of the big story called the drug industry over the past several years has been the patent cliff, the steady loss of patent protection on blockbuster primary care drugs and subsequent generic competition that has forced many drug companies to find new revenue streams. Much of this has taken place in the form of a gradual shift to specialty drugs for such conditions as cancers and autoimmune disorders, but recent developments have shown that primary care drugs may still have some steam left in them.


February 17, 2012

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 14, 2012

Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

PITTSBURGH — Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

Sunovion Pharmaceuticals sued Mylan and several subsidiaries in the U.S. District Court for the District of Delaware when the latter sought to market a generic version of Sunovion's Xopenex (levalbuterol hydrochloride) inhalation solution, a drug for asthma and chronic obstructive pulmonary disease. The jury's verdict includes an $18 million award.

February 7, 2012

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

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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December 14, 2011

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 2, 2011

ABC's "Nightline: Late Evening News" on Wednesday aired an exposé on Kentucky's methamphetamine problem, shadowing law enforcement as they made three arrests in a state that employs an electronic tracking system for the over-the-counter ingredient pseudoephedrine. The officers investigated sales made at Walgreens, CVS and Walmart.

NEW YORK — ABC's "Nightline: Late Evening News" on Wednesday aired an exposé on Kentucky's methamphetamine problem, shadowing law enforcement as they made three arrests in a state that employs an electronic tracking system for the over-the-counter ingredient pseudoephedrine. The officers investigated sales made at Walgreens, CVS and Walmart.

December 2, 2011

Six retailers on Wednesday filed suit naming Wyeth and Teva Pharmaceuticals as defendants and alleging that the defendants unlawfully delayed the entry of generic versions of Wyeth's antidepressant Effexor XR (venlafaxine).

TRENTON, N.J. — Six retailers on Wednesday filed suit naming Wyeth and Teva Pharmaceuticals as defendants and alleging that the defendants unlawfully delayed the entry of generic versions of Wyeth's antidepressant Effexor XR (venlafaxine). A summons was issued to Wyeth and Teva on Thursday.

The retailers include Ahold USA, H-E-B, Kroger, Safeway, Supervalu and Walgreens. The companies are suing for three-times damages plus attorneys fees.

Wyeth was acquired by Pfizer in October 2009.

September 22, 2011

Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.

SAN DIEGO — Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.