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Regulatory and Washington

  • Enough flu vaccines to go around - just not everywhere at once

    Amid an unusually strong flu season that the Centers for Disease Control and Prevention has called an epidemic, supplies of flu vaccines are running low, and some people hoping to get immunized are having trouble finding them.

  • FDA panel recommends approval for J&J Type 2 diabetes drug

    RARITAN, N.J. -- A panel of Food and Drug Administration experts has recommended approval for an experimental Type 2 diabetes drug made by Johnson & Johnson, the drug maker said.

    J&J said the FDA's Endocrinologic and Metabolic Drugs Advisory Committee had recommended approval for canagliflozin, which the company plans to market under the name brand Invokana. The FDA is not required to follow the votes of advisory committees when deciding whether or not to approve a drug, but usually does.

  • CDC: Influenza rates may have reached a peak, at least in the Southeast

    ATLANTA — The worst of the flu season may be over, at least for those in the South. In a late morning press conference with reporters, Thomas Frieden, director of the Centers for Disease Control and Prevention, said, "We are seeing a decrease in some regions."

  • FDA approves Wockhardt epilepsy drug

    PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic epilepsy drug made by Wockhardt, the company said.

    Wockhardt, based in India, announced the approval of lamotrigine extended-release tablets in the 25-mg, 50-mg, 100-mg, 200-mg and 300-mg strengths.

    The drug is a generic version of GlaxoSmithKline's Lamictal XR. The U.S. market for the drug is about $250 million, according to IMS Health.

  • FDA approves Bayer IUD

    WAYNE, N.J. — The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.

    Bayer announced the approval of Skyla (levonorgestrel-releasing uterine system), which can prevent pregnancy for up to three years. The IUD contains 13.5 mg of levonorgestrel.

    Nearly 50% of pregnancies in the United States are unintended, according to the National Center for Health Statistics.

  • U.S. lags other developed countries in health, life expectancy, report finds

    WASHINGTON — A new report gives low marks to the United States in the health of its citizens, finding that Americans have higher rates of injury and disease and die sooner than their counterparts in other developed countries.

  • FDA calls for lower dosage in some insomnia drugs

    SILVER SPRING, Md. — The Food and Drug Administration is ordering the makers of several sleep drugs to lower the recommended dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

    The FDA announced that it was requiring the manufacturers of drugs containing the active ingredient zolpidem to lower the current recommended dosage in light of new data showing that the morning after use, the drug can remain in the blood in sufficient quantities to impair activities that require alertness, such as driving.

  • HHS announces 106 new ACOs, including three affiliated with Walgreens

    DEERFIELD, Ill. — Advocare Walgreens Well Network, Diagnostic Clinic Walgreens Well Network and Scott & White Walgreens Well Network have been selected as three of 106 new Accountable Care Organizations in Medicare, Health and Human Services Secretary Kathleen Sebelius announced Thursday.

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