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Regulatory and Washington

  • BB&T rescinds mandatory mail Rx proposal, drawing praise from independent pharmacies

    ALEXANDRIA, Va. — The nation’s top independent pharmacy group is hailing a recent decision by a major corporation to maintain freedom of choice of where its employees fill their maintenance prescription medicines.

    The National Community Pharmacists Association today applauded BB&T's decision to reemphasize and continue its employees' choice in filling their maintenance prescriptions, including at independent community pharmacies. The revised policy was communicated to BB&T employees last week.

  • FDA accepts application for extended-release Janumet

    WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug to treat Type 2 diabetes made by Merck, the drug maker said Tuesday.

    Merck announced the acceptance of its application for extended-release Janumet, which combines in a single pill the active ingredient sitagliptin with extended-release metformin, a drug commonly prescribed for Type 2 diabetes.

  • Endo receives complete response letter for crush-resistant Opana ER

    CHADDS FORD, Pa. — The Food and Drug Administration declined to approve Endo Pharmaceuticals’ regulatory application for a painkiller designed to thwart drug abusers, Endo said Friday.

  • Watson's generic Fentora gets FDA approval

    MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related pain, Watson said Monday.

    Watson announced the approval of fentanyl buccal tablets in the 0.1-mg, 0.2-mg, 0.6-mg and 0.8-mg strengths.

  • N.Y. politician looks to make medicine cups, dosage devices safer for children

    HUNTINGTON, N.Y. — Rep. Steve Israel, D-N.Y., plans to introduce new legislation soon to make medicine cups and other dosage devices commonly used to give medicine to children safer, the Congress leader recently announced. However, the need for such a bill may be moot as the over-the-counter industry already is actively initiating guidelines to standardize dosing directions and units of measuring that dose.

  • Abstral OKed as breakthrough pain treatment for cancer patients

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating pain in cancer patients, the agency said Friday.

    The FDA announced the approval of ProStrakan’s Abstral (fentanyl) transmucosal tablets for the management of pain that appears suddenly for short periods and is not alleviated by a patient’s normal pain-management plan, also known as breakthrough pain. The tablets are designed for administration on the soft surfaces of the mouth, including inside the cheek, gums and tongue, as well as the nasal passages or the throat.

  • CRN announces monthly blog

    WASHINGTON — The Council for Responsible Nutrition on Friday announced a partnership with New Hope Natural Media’s NPIcenter, in which CRN will provide a monthly blog commentary posted on the supplement industry website, NPIcenter.com, as well as on the newly launched NewHope360.com.

  • Warning issued to consumers over extortionists posing as FDA agents, federal officials

    SILVER SPRING, Md. — International criminals are posing as Food and Drug Administration special agents and other law enforcement officers in order to extort money from consumers, the FDA warned Friday.

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