PHARM.D

New Once-Daily LABA Improves Lung Function in COPD   After a month of using vilanterol, an investigational long-acting beta-2-agonist (LABA) that's inhaled once a day, patients with moderate to severe chronic obstructive pulmonary disease (COPD) had significant improvements in forced expiratory volume in 1 second (FEV1). "The 25 mcg and 50 mcg doses of vilanterol appear to offer the greatest clinical benefit without any safety concerns," the authors reported online January 12 in Chest. Dr. Nicola A. Hanania, with Baylor College of Medicine in Houston, Texas, and colleagues note that once-daily dosing of a LABA could improve patient compliance. To assess dose response, efficacy and safety, the researchers enrolled 602 patients with moderate-severe disease and randomly assigned them to 3.0, 6.5, 12.5, 25, or 50 mcg vilanterol, or placebo, inhaled once daily for 28 days. The main outcome measure was the change in trough FEV1 from baseline to the end of the study....

Ranbaxy launches generic version of Lipitor in the U.S. market Ranbaxy Laboratories on Thursday announced the launch of its generic version of its much sought after cholesterol-lowering drug Lipitor in the U.S. market. The announcement of the launch came following the final approval from the U.S. health regulator to manufacture the generic version of Lipitor at the Ranbaxy's wholly owned Ohm Laboratories facility in New Brunswick, New Jersey, as well as market the product. “Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of Ranbaxy Laboratories, has received final approval from the U.S. Food and Drug Administration to manufacture and market Atorvastatin and has launched the product in the U.S. market,'' the company said in a statement issued here. Ranbaxy CEO and Managing Director Arun Sawhney, referring to the latest development, said: “Atorvastatin helps millions of Americans manage healthy cholesterol levels and we are pleased to have received USFDA approval to m...

FDA Updates Warnings on Methylene Blue, Linezolid, and Serotonergics The US Food and Drug Administration (FDA) has fine-tuned a warning issued in July to avoid prescribing either methylene blue or linezolid ( Zyvox , Pfizer) in combination with serotonergic agents because of the potential to cause serotonin syndrome. Today, the FDA announced that the risk for this harmful interaction appears to be confined, in general, to 2 specific types of serotonergic drugs: selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors. Methylene blue is a dye used in diagnostic procedures and in the treatment of conditions ranging from cyanide poisoning to methemoglobinemia. Linezolid is an antibacterial agent. Both drugs inhibit the action of monoamine oxidase A, an enzyme that breaks down serotonin. This allows the levels of the neurotransmitter to ...

FDA Approves First Generic Versions of Levofloxacin Tinker Ready The US Food and Drug Administration (FDA) yesterday approved applications from 12 companies to manufacture generic versions of levofloxacin ( Levaquin , Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson), a widely used fluoroquinolone antibiotic. The companies, including Teva Pharmaceutical and Sandoz Inc, will start producing generic levofloxacin now that Johnson & Johnson's patent has expired. The drug has been a blockbuster for the company. In the United States, Levaquin had sales of $1.3 billion in 2010 and $422 million in the first quarter of 2011, according to news sources. Levofloxacin is the second common drug in its class to become available in generic form. Another fluoroquinolone, ciprofloxacin ( Cipro , Bayer) is also available generically. The patent for a third drug in the same class, moxifloxacin ( Avelox , Schering Corp, a subsidiary of Merck & Co), expir...