A global leader in serving libraries of all types, ProQuest LLC (“ProQuest”) supports the breadth of the information community with innovative discovery solutions that power the business of books and the best in research experience. More than a content provider or aggregator, ProQuest is an information partner, creating indispensable research solutions that connect people and information. Through innovative, user-centered discovery technology, ProQuest offers billions of pages of global content that includes historical newspapers, dissertations, and uniquely relevant resources for researchers of any age and sophistication—including content not likely to be digitized by others.
p38 Industry news.qxp 6/24/09 2:30 PM Page 1 38 Renal & Urology News JULY 2009 Industry News FDA UPDATE AND PRODUCT NEWS FDA Update Product News n Hyponatremia Drug Receives Marketing Clearance The FDA has approved Samsca tablets (tolvaptan) to treat hyponatremia, one Cook Medical to Market of the most common electrolyte disorders seen in hospitalized patients. Hyponatremia is associated with heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic Pneumatic Lithotripter hormone. According to the drug’s manufacturer, Otsuka Pharmaceutical Co., Ltd., in AS A RESULT of a partnership with LMA Urology, of Gland, Tokyo, Samsca is the only oral selective vasopressin antagonist available for treating Switzerland, Cook Medical, of hyponatremia. Samsca raises and maintains serum sodium concentrations by increas- Bloomington, Ind., has added a new ing the excretion of free water (aquaresis) without directly affecting the excretion of lithotripter to its kidney stone treat- sodium or impacting kidney function. In the Study of Ascending Levels of Tolvaptan in ment line. Hyponatremia 1 and 2 clinical trials, 424 patients with euvolemic or hypervolemic Called the LMA StoneBreaker, the hyponatremia (serum sodium less than 135 mEq/L) were treated for 30 days with device is a portable pneumatic Samsca or placebo, then followed for an additional seven days after cessation. As soon lithotripter powered by a cartridge as eight hours after the first dose, patients using the drug experienced an increase in of high-pressure carbon dioxide. for fragmentation and stone remov- sodium levels greater than those seen with placebo. Samsca should be initiated only in a The StoneBreaker’s compact, ergo- al. StoneBreaker delivers a high- nomic design makes it easier to er probe-tip velocity at impact to hospital, where patients’ serum sodium can be monitored closely, as too rapid a rise in manage than comparable litho- successfully break stones in one sodium can cause osmotic demyelination syndrome. tripters, reducing the procedure time procedure. n n First Topical Gel for Overactive Bladder Approved Watson Pharmaceuticals, Corona, Calif., has received approval for Gelnique (oxybutynin chloride) Gel 10%, the first and only topical gel for the treatment of overactive bladder Panel Recommends Approval (OAB). The quick-drying, clear, colorless, and fragrance-free hydroalcoholic gel is applied once daily to the thigh, abdomen, of Drug for Refractory Gout upper arm, or shoulder to relieve OAB symp- THE FDA’s Arthritis Drugs Advi- said in a press release that the advisory toms, including urge urinary incontinence, sory Committee has recommended committee’s recommendation sup- urgency, and frequency. that Krystexxa (pegloticase) be ap- ports the company’s belief that the Gelnique is delivered transdermally so it proved for the treatment of refractory drug has a favorable risk-to-benefit chronic gout. The FDA has granted profile in patients with refractory avoids first-pass metabolism, thus decreasing orphan drug status to pegloticase, a chronic gout. The FDA granted prior- formation of the N -desethyloxybutyin metabo-
Pages to are hidden for
"FDA Update - Get as PDF"Please download to view full document