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Regulatory and Washington

  • Mylan can launch generic diabetes drug in August

    PITTSBURGH — Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

    The generic drug maker said that under the agreement, it can launch a generic version of Shionogi's Fortamet (metformin hydrochloride) extended-release tablets in the 500-mg and 1,000-mg strengths on Aug. 1.

    Metformin hydrochloride extended-release tablets in those two strengths had sales of about $125 million during the 12-month period that ended in September, according to IMS Health.

     

  • Retailer taken to task for iterating supplement claim found on NIH information page

    BAKERSFIELD, Calif. — Walgreens was singled out in a lawsuit earlier this week here for suggesting a vitamin E supplement may help improve cardiovascular health. 

    Specifically, according to a Reuters report Monday, the complainant stated that Walgreens' Vitamin E 400 IU purported to "naturally contribute to cardiovascular health by helping to protect LDL cholesterol from oxidation which may cause cellular damage." 

  • Meryl Streep appears in colorectal cancer-screening campaign

    LOS ANGELES — Actress Meryl Streep will encourage people to get screened for colorectal cancer in a new series of public service announcements from the Entertainment Industry Foundation's National Colorectal Cancer Research Alliance and the Centers for Disease Control and Prevention, the groups said Wednesday.

  • NIH: Weight gain does not outweigh smoking cessation in risk of CVD

    BETHESDA, Md. — The improvement in cardiovascular health that results from quitting smoking far outweighs the limited risks to cardiovascular health from the modest amount of weight gained after quitting, according to a National Institutes of Health-funded community study released Wednesday. 

  • NCPA supports Ore. reimbursement, audit, pharmacy choice legislation

    NEW YORK — Bills introduced in Oregon's state legislature would allow employers and other health plan sponsors to have greater knowledge about how pharmacy benefit managers determine the rates at which they pay pharmacies for dispensing generic drugs; establish new standards for pharmacy audits while requiring PBMs to register in the state and be licensed by the state board of pharmacy; and prevent health plans from requiring residents of the state to use mail-order pharmacies.

  • Retail sales rise 1.1% in February

    WASHINGTON — Retail sales for the month of February rose by 1.1% seasonally adjusted month to month, according to figures released Wednesday by the Department of Commerce.

    The newly released figures include nongeneral merchandise categories, such as automobiles, gas stations and restaurants; excluding those, sales rose 0.7%, while rising 0.5% unadjusted year over year. The National Retail Federation noted that sales beat estimates as consumers adapted and adjusted spending in response to higher gas prices and the payroll tax increase.

  • Actavis seeks approval for Alzheimer's patch

    PARSIPPANY, N.J. — Actavis is challenging Novartis' patent on a patch used to treat Alzheimer's disease, Actavis said.

    The generic drug maker said it had filed with the Food and Drug Administration an amendment to its regulatory application for rivastigmine transdermal system to include the 13.3 mg-per-24-hours dosage strength, a generic version of Novartis' Exelon. Novartis filed suit against Actavis on Thursday in the U.S. District Court for the District of Delaware seeking to prevent commercialization of the generic version.

  • Former Bayer executive wins CHPA award

    WASHINGTON — The former president of Bayer HealthCare's Worldwide Consumer Care Division has won a lifetime-achievement award from a trade group focused on the OTC industry.

    The Consumer Healthcare Products Association announced that it gave its Ivan D. Combe Lifetime Achievement Award to Gary Balkema at its annual executive conference in Naples, Fla.

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