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Regulatory and Washington

  • Lannett receives FDA approval for generic Microzide

    PHILADELPHIA — Lannett announced that it has received approval from the Food and Drug Administration to market its version of a hypertension treatment.

    The drug maker said its abbreviated new drug application for hydrochlorothiazide capsules in the 12.5-mg strength was approved. The drug is a generic version of Watson Pharmaceuticals' Microzide capsules.

  • FDA approves Genentech skin cancer drug

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating the most common type of skin cancer, the agency said Monday.

    The FDA announced the approval of Genentech's Erivedge (vismodegib) for adults with basal cell carcinoma who are not surgery or radiation therapy candidates and whose disease is locally advanced or has spread to other parts of the body.

  • Watson, Mallinckrodt settle over generic painkiller

    PARSIPPANY, N.J. — Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.

  • Mead Johnson announces ad campaign to restore trust in Enfamil

    GLENVIEW, Ill. — Mead Johnson Nutrition CEO Stephen Golsby on Thursday announced that the company will be deploying a significant ad campaign to recapture any lost trust among moms because of an Enfamil "pull-and-hold" in December.

    Retailers had pulled the product off their shelves out of an abundance of caution — the product had been consumed in the days prior to a child's death — but both the Food and Drug Administration and the Centers for Disease Control and Prevention later vetted Enfamil from having any link to that tragedy.

  • FDA approves Pfizer's Inlyta for advanced kidney cancer

    SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

    The FDA announced the approval of Inlyta (axitinib) for patients with advanced kidney cancer, also known as renal cell carcinoma, who have not responded to another drug for the disease. The drug, a twice-daily pill, works by blocking certain proteins called kinases that are involved with tumor growth and disease progression.

  • Harvard doctor calls for greater supplement regulation in NEJM

    WASHINGTON — The New England Journal of Medicine on Thursday published an op-ed online that called for more rule-making to govern dietary supplements in an effort to rein in the criminal activity of illicit prescription drug manufacturers that openly disregard the laws currently in effect.

  • Reports: Fla. pharmacists hope to administer pneumonia, shingles shots

    NEW YORK — Pharmacists in Florida are hoping to expand the kinds of vaccinations they can administer, according to published reports.

    Tallahassee, Fla., CBS affiliate WTSP reported that a bill proposed in the state legislature would allow pharmacists to administer shots to prevent pneumonia and shingles. While pharmacists in Florida have been able to administer flu shots since 2007, the state remains one of the few where they can't administer pneumonia and shingles shots.

    A committee in the state House of Representatives voted in favor of the bill, WTSP reported.

  • Federal court clears way for Watson, Amphastar to launch generic version of Lovenox

    PARSIPPANY, N.J. — A federal court has stopped an injunction that would have prevented drug maker Watson Pharmaceuticals and partner company Amphastar Pharmaceuticals from marketing or selling a generic version of a blood-thinning drug.

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