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      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-
								
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