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Regulatory and Washington

  • FDA advisory committee votes in favor of GSK's Votrient

    PHILADELPHIA — A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

    GSK announced that the FDA Oncologic Drugs Advisory Committee voted 11-2 that clinical trial data indicated a favorable risk-benefit profile of the drug Votrient (pazopanib) in patients with advanced soft-tissue sarcoma who have received chemotherapy. The drug is already approved for treating the kidney cancer renal cell carcinoma.

  • Safeway joins USDA on national health-and-wellness communication initiative

    PLEASANTON, Calif. — Safeway on Tuesday joined forces with the U.S. Department of Agriculture's Center for Nutrition Policy and Promotion on an initiative to develop and promote dietary guidance that links scientific research to the nutrition needs of consumers.

  • Watson challenges Abbott patent on Niaspan

    PARSIPPANY, N.J. — Watson Pharmaceuticals is challenging the patent protection on a drug made by Abbott for treating cholesterol, the company said.

    Watson, through a subsidiary, filed with the Food and Drug Administration for approval of niacin extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is a generic version of Abbott's Niaspan.

  • FDA approves generic versions of osteoporosis drug

    SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic version of a drug for treating and preventing osteoporosis in women after menopause, the agency said Monday.

    The FDA announced the approval of ibandronate tablets in the 150-mg strength made by Apotex, Orchid Healthcare and Mylan Pharmaceuticals. Genentech makes the branded version of the drug.

  • NCPA applauds local pharmacist for participation in Dispose My Meds

    ALEXANDRIA, Va. — The National Community Pharmacists Association has applauded a member of its organization for participating in the organization's drug disposal program.

  • Appeals court lifts stay; suspension of Cardinal's Fla. distribution center license reinstated

    WASHINGTON — Cardinal Health's appeal to delay a Drug Enforcement Agency suspension of its license to distribute controlled substances out of its Lakeland, Fla., distribution center was denied Friday by the U.S. Court of Appeals for the District of Columbia Circuit. The ruling lifts a previously granted emergency stay issued by the appellate court earlier this month.

  • Affordable Care Act helped seniors, people with disabilities save more than $3 billion on Rxs

    WASHINGTON — More than 5.1 million seniors and people with disabilities on Medicare saved billions on prescription drugs, thanks to the Patient Protection and Affordable Care Act, according to Department of Health and Human Services secretary Kathleen Sebelius.

    New data found that these individuals saved more than $3.2 billion on prescription drugs, while savings for seniors included a one-time $250 rebate check to those who hit the "donut hole" coverage gap in 2010 and a 50% discount on covered brand-name drugs in the donut hole in 2011.

  • NACDS praises N.J. legislators for resolution urging governor to oppose PBM mega-merger

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores is praising lawmakers in Medco Health Solutions’ home state of New Jersey for delivering what NACDS called “a bold and revealing blow” to the PBM’s proposed merger with Express Scripts.

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