Content about Phenethylamines

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.

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.

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

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.

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.


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).

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.

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.

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.

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.

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.

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.