Amneal Pharmaceuticals, LLC has announce that it has received U.S. FDA approval to manufacture Spironolactone HCl tablets in 25 mg, 50 mg and 100 mg strengths effective July 2, 2010. The Amneal generic is an AB-rated, therapeutically equivalent alternative to Aldactone® (a registered trademark of Pharmacia & Upjohn, Inc., a unit of Pfizer Inc.). Annual U.S. sales of Spironolactone HCl were $91 MM as of December 2009 according to IMS Health market data.

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NephRx Corporation announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead product NX001 for the prevention of delayed graft function (DGF) in renal transplant recipients. NX001 is a kidney growth factor peptide that has demonstrated good safety and promising efficacy in two animal models of acute renal failure. DGF affects an estimated 20-25% of the approximately 14,000 renal transplants performed annually in the U.S.

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Genentech, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease. The supplemental approval is based on data that showed longer prophylactic treatment with Valcyte reduced the incidence of CMV disease in high-risk adult kidney transplant patients from 36.8 percent to 16.8 percent at one year after receiving a transplanted kidney.

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Antares Pharma, Inc. has announced positive results from its Phase 3 study of AnturolTM Gel in patients with overactive bladder (OAB). The study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied (56 mg daily or 84 mg daily, p=0.028 and 0.033 respectively). An Open Label Extension study, evaluating long term safety remains ongoing and is scheduled to complete by Q4 2010.

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Siemens Healthcare announces FDA clearance for the UROSKOP® Omnia, its new multifunctional workstation for urology. The workstation’s new dynamic flat detector technology UROSKOP Omnia allows the urologist to cover the entire urinary tract – kidney, ureter, bladder (KUB) – with only one single exposure and in superb image quality. With its curved X-ray column, UROSKOP Omnia offers truly unrestricted patient access from all table sides.

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A California-based food company announced a voluntary recall of romaine lettuce salad products suspected of being tainted with E. Coli O157:H7. The company said it ordered the recall after a random test by the U.S. Food and Drug Administration detected E. coli O157:H7 in one package of Fresh Express Hearts of Romaine lettuce salad. While most healthy adults recover within a week, young children and elderly are at higher risk for developing Hemolytic Uremic Syndrome (HUS) as a result of the infection. HUS can lead to serious kidney damage and death.

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Watson Pharmaceuticals Inc (WPI) said its unit applied for Food and Drug Administration approval of a generic version of Genzyme Corp.’s (GENZ) Renvela kidney-failure product. Renvela is a phosphate-binder, which dialysis patients need to absorb excess phosphorous in the blood, a problem associated with increased risk of cardiac issues.
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American Medical Systems has announced that the U.S. Food and Drug Administration (FDA) has approved the company’s MiniArc Precise single-incision sling system for the treatment of female stress urinary incontinence (SUI). MiniArc Precise is the successor to American Medical’s original MiniArc sling system (launched in 2007), the largest selling single-incision sling in the U.S. having been implanted in more than 75,000 patients.

Federal regulators are warning doctors not to use the malaria drug Qualaquin to treat leg cramps, due to the risk of potentially life-threatening blood disorders and kidney damage. In its communication, the FDA has noted that doctors have been prescribing Qualaquin “off label” for the treatment of leg cramps, but they warn that the drug should not be prescribed for this purpose because it carries a risk of life-threatening blood and kidney

The degradation of proteins and other macromolecules in cells is vital to survival. Disruption of this process can result in serious disease. The research group at FMP and MDC has now succeeded in identifying an essential cellular process necessary for the transport and degradation of macromolecules in endosomes and lysosomes, respectively. A standard treatment for prostate cancer that has spread to the bones is with a drug approved by the FDA called samarium 153.

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