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  • FDA Approves First in a New Class of Drugs to Treat Hyperparathyroidism Associated With Renal Failure and in Patients With Parathyroid Cancer
    FDA has approved Sensipar (cinacalcet), a drug to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, and hypercalcemia in patients with parathyroid cancer. Cinacalcet is the first drug in the class of compounds known as calcimimetics to be approved by the FDA. It is approved as a treatment for secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. Elevated levels of parathyroid hormone (PTH), the hallmark of secondary...
    U.S. Food and Drug Administration
  • FDA Approves First in New Class of Antibiotics
    The Food and Drug Administration (FDA) today announced the approval of Cubicin (daptomycin for injection) for the treatment of complicated skin and skin structure infections. These are serious infections, usually occurring in hospitalized patients, and include major abscesses, post-surgical skin wound infections, and infected ulcers. Cubicin is the first approved product in a new class of antibiotics called cyclic lipopeptide antibacterial agents. Cubicin treats infections in a way that is...
    U.S. Food and Drug Administration
  • Cooking Up the New Food Label
    by Judith E. Foulke Reading the new food labels required on almost all foods will make planning healthy diets easier for consumers. Writing the regulations that spell out what should be on those labels has been everything but easy for the rule-makers. Ask any number of Food and Drug Administration and U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) staffers who were involved in writing the regulations. They'll say that in almost every instance, before pen met paper...
    U.S. Food and Drug Administration

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July 30, 2010



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