Regulatory and Washington

  • Mylan gets green light for generic hypertension treatment

    PITTSBURGH Mylan subsidiary Mylan Technologies has received final approval from the Food and Drug Administration for its hypertension treatment, the generic drug maker said.

    Mylan said its clonidine transdermal system USP was approved in the 0.1 mg/day, 0.2 mg/day and 0.3 mg/day strengths. Mylan's CTS is the generic version of Boehringer Ingelheim's Catapres-TTS.

     

  • Personal Care Products Council supports expanded FDA role in industry oversight

    WASHINGTON The Personal Care Products Council announced on July 15 that it is calling for a greater role by the Food and Drug Administration in regulatory oversight of personal care products and assessing ingredient safety.

    The announcement came less than a week before the introduction of the Safe Cosmetics Act of 2010 in Congress by Reps. Jan Schakowsky, D-Ill., Ed Markey, D-Mass., and Tammy Baldwin, D-Wis.

  • 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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