Drug Topics - May 19, 2008 - (Page 5) 5 NEWS Roundup< < < Rx Care Osteoporosis drug cleared for use once per month Actonel (risedronate sodium), available in daily, weekly, and two-tablets-per-month dosage forms, has now been approved for once-a-month (150 mg) use. Co-promoted by Procter & Gamble and sanofi-aventis, the bisphosphonate is designed to reduce the risk of fractures in postmenopausal women with osteoporosis. Biovail receives approval for new antidepressant Aplenzin (bupropion hydrobromide), formerly known as BVF-033, is an antidepressant from Biovail Corp. that has just received approval from the Food & Drug Administration. The Toronto firm said that it is in discussions with various companies on how to distribute the drug in this country. What distinguishes the product, which comes in 175-mg, 348-mg, and 522mg extended-release tablets, is it' s an alcohol-resistant formulation of a new bupropion salt. The 522-mg dosage strength provides the maximum allowable dose of bupropion in a single once-daily tablet. Glaxo' s Advair gets nod for exacerbation reduction Advair Diskus 250/50, from GlaxoSmithKline, may now be used for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) who have a history of exacerbations. The combination drug, which contains fluticasone propionate 250 mcg and salmeterol 50 mcg, was proven effective for this new indication in two one-year clinical trials involving a total of 1,579 patients. Patients treated with Advair had a 30% reduction in the rate of annual exacerbations compared with salmeterol and a significantly lower annual rate of exacerbations requiring treatment with oral corticosteroids. The new approval expands the use of the inhalation powder to include patients with emphysema in addition to chronic bronchitis, which was the target population of the product' s original approval back in 2003. Cefixime tablets make return to market Since 2002, when Wyeth Pharmaceuticals discontinued manufacturing cefixime 400-mg tablets, the availability of the drug has been limited in the United States to the production of cefixime oral suspension in 100 mg/5 ml and 200 mg/5 ml strengths by Lupin Pharmaceuticals. Now Lupin has announced it will start making the antibiotic in a 400-mg tablet. Cefixime is the only oral agent currently recommended by the Centers for Disease Control & Prevention for the treatment of uncomplicated urogenital or rectal gonnorhea. New injection relieves symptoms of Crohn' s disease Crohn' s disease patients have a new monthly treatment option open to them. It' s UCB' s Cimzia (certolizumab pegol), an injectable which reduces the symptoms of this chronic inflammatory bowel disease, ranging from diarrhea to abdominal pain. Because the drug carries risks that require patients to be closely monitored, pharmacists must dispense a Medication Guide along with the product. UCB claims Cimzia is the first and only PEGylated anti-tumor necrosis factor alpha antibody indicated for this disease, which affects more than one million people worldwide. Second indication approved for Amitiza Sucampo and Takeda Pharmaceuticals have been granted approval to market lubiprostone (Amitiza) to treat irritable bowel syndrome with constipation (IBSC) in adult women. According to the manufacturers, lubiprostone is the first prescription drug to treat IBSC in the United States, a condition that affects twice as many women as men. In two studies involving 1,154 patients, more patients receiving lubiprostone reported their IBS symptoms were moderately or significantly relieved over a 12-week treatment period than patients who received placebo. The new indication calls for the drug to be taken in an 8-mcg dose twice daily with food and water. Lubiprostone was previously approved to treat chronic idiopathic constipation in a 24-mcg twice-daily dosage. Digoxin recalled after toxicity reports Actavis Totowa LLC has issued a Class I nationwide recall of all strengths of its digoxin tablets (Digitek) after discovering that some of the tablets may contain twice the appropriate amount of active ingredient. The tablets are distributed by Mylan Pharmaceuticals, under a ª Bertekº label, and by UDL Laboratories, under a ª UDLº label. Customer inquiries related to the recall should be directed to Stericycle customer service at 1-(888)-276-6166.
Table of Contents Feed for the Digital Edition of Drug Topics - May 19, 2008 Drug Topics - May 19, 2008 Contents How Drug Plans Can Survive Their Part D Audit Pharmacists Key to Medication Therapy Management Success Latest News Roundup Drug Topics - May 19, 2008 Drug Topics - May 19, 2008 - Contents (Page 1) Drug Topics - May 19, 2008 - Contents (Page 2) Drug Topics - May 19, 2008 - How Drug Plans Can Survive Their Part D Audit (Page 3) Drug Topics - May 19, 2008 - Pharmacists Key to Medication Therapy Management Success (Page 4) Drug Topics - May 19, 2008 - Latest News Roundup (Page 5) Drug Topics - May 19, 2008 - Latest News Roundup (Page 6)
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