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Regulatory and Washington

  • Walgreens' Kang joins National Committee for Quality Assurance board

    DEERFIELD, Ill. — The National Committee for Quality Assurance on Monday named Jeffrey Kang, Walgreens SVP pharmacy, health and wellness services and solutions, to its board.

    NCQA is a private nonprofit organization that accredits and certifies a wide range of healthcare organizations. The group also recognizes clinicians and practices in key areas of performance. NCQA's Healthcare Effectiveness Data and Information Set is the most widely used performance measurement tool in health care, the committee stated.

  • Berwick steps down from post as CMS administrator

    WASHINGTON — The Obama administration confirmed last week that Centers for Medicare and Medicaid Services administrator Donald Berwick will step down from his post on Dec. 2.

    Berwick, who was nominated to the position by President Obama in April 2010, was supposed to lead the agency through the end of the year as part of his recess appointment.

    Marilyn Tavenner, CMS principal deputy administrator, will succeed Berwick, according to a statement made by Health and Human Services secretary Kathleen Sebelius.

  • Perrigo gains approval for store brand Mucinex

    ALLEGAN, Mich. — Perrigo on Monday announced that it received final approval from the Food and Drug Administration for its store-brand version of Mucinex tablets.

    Perrigo is still in litigation with Reckitt Benckiser involving the introduction of a private-label Mucinex. "Perrigo is working through the litigation and expects to begin shipping this product in our retail and wholesale customers' store brand packaging in the second half of our fiscal year," Perrigo chairman and CEO Joseph Papa said.

  • CDC: Elderly patients at risk of emergency hospitalizations from blood thinners, diabetes medications

    ATLANTA — Many elderly patients put themselves at risk for emergency hospitalization due to adverse drug events, according to a new Centers for Disease Control and Prevention study published in the New England Journal of Medicine.

  • Pennsylvania Pharmacy Council expresses opposition of planned ESI-Medco merger

    CAMP HILL, Pa. — The merger between pharmacy benefit managers Express Scripts and Medco Health Solutions "could bring an end to community-based pharmacies and the convenient services provided there," according to the Pennsylvania Pharmacy Council.

  • Takeda files for approval of alogliptin-metformin combination tablet

    OSAKA, Japan — A U.S. subsidiary of Takeda Pharmaceutical has filed for regulatory approval of a drug designed to treat Type 2 diabetes, the company said.

    The Takeda Global Research and Development Center filed with the Food and Drug Administration for approval of an alogliptin-metformin combination tablet. The company expects the FDA to review the application within the next 10 months.

  • FDA files permanent injunction against ATF Fitness Products

    SILVER SPRING, Md. — The Food and Drug Administration last week took legal action against the dietary supplement manufacturer ATF Fitness Products for substituting ingredients and products without noting the changes on the final product labels.

    The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug and Cosmetic Act. Brands include Sci-Fit, Nature's Science and For Store Only.

  • FDA approves Mylan chemoprotective agent

    PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for cancer patients.

    Mylan announced Monday the approval of dexrazoxane for injection, a generic version of Pharmacia & Upjohn's Zinecard. The drug is a chemoprotective agent, used to protect healthy tissue from cancer drugs.

    Various versions of the drug had sales of $3.4 million during the 12-month period ended in September, according to IMS Health.

     

     

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