Regulatory and Washington

  • Mylan's generic arthritis drug receives FDA approval

    PITTSBURGH The Food and Drug Administration has approved a generic arthritis treatment made by Mylan, the drug maker said Wednesday.

     

    The FDA approved nabumetone tablets, a treatment for osteoarthritis and rheumatoid arthritis, in the 500 mg and 750-mg strengths.

     

     

  • Watson seeks FDA approval for generic Renvela, confirms patent challenge

    MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals hopes to be the first to market a version of a kidney disease treatment made by Genzyme, Watson said Monday.

    Watson said it filed a regulatory approval application with the Food and Drug Administration for sevelamer carbonate for oral suspension. The drug is a generic version of Genzyme’s Renvela, used to control serum phosphorus in patients with chronic kidney disease who are on dialysis.

     

  • Report, PCPC sniff out truth on fragrances’ safety

    WASHINGTON —A new report by activist group Campaign for Safe Cosmetics alleging that a number of popular brand-name perfumes and teen body sprays have “secret” chemicals that could be harmful to consumers is “erroneous” and “does a disservice to consumers,” stated John Bailey, chief scientist of the Personal Care Products Council, in response to the claim.

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