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Regulatory and Washington

  • FDA panel unanimously recommends approval of Eylea

    TARRYTOWN, N.Y. — A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

    Regeneron said Friday that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended approval of Eylea (aflibercept) ophthalmic solution for the treatment of a form of age-related macular degeneration, also known as wet AMD. The disease causes abnormal growth of new blood vessels in the eye.

  • Abbott receives FDA approval for Lupron Depot

    ABBOTT PARK, Ill. — The Food and Drug Administration has approved a new formulation of an injectable drug made by Abbott for prostate cancer.

    Abbott announced Monday the approval of a 45-mg, six-month formulation of Lupron Depot (leuprolide acetate) for advanced prostate cancer. Previous formulations have allowed patients to receive the drug every month or every three or four months.

  • Watson's nabumetone tablets get FDA OK

    PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for arthritis made by Watson Pharmaceuticals, Watson said Friday.

    The drug maker announced the approval of nabumetone tablets in the 500-mg and 750-mg strength. The drug is used to treat signs and symptoms of rheumatoid arthritis and osteoarthritis.

    Nabumetone had sales of $58 million during the 12-month period ended in April, according to IMS Health.

  • CDC: Retail settings become popular alternative for flu shots

    ATLANTA — Many adults across the United States opted to visit their local drug store or supermarket to receive their flu shot during the 2010-2011 influenza season, according to the Centers for Disease Control and Prevention's "Morbidity and Mortality Weekly Report."

  • FDA updates ongoing safety review of Actos

    SILVER SPRING, Md. — The Food and Drug Administration on Thursday informed the public that continued use of a Type 2 diabetes treatment made by Takeda Pharmaceuticals for more than one year may be associated with an increased risk of bladder cancer.

  • CHPA praises North Carolina's passage of PSE sales blocking technology legislation

    WASHINGTON — The North Carolina legislature passed a real-time, stop-sale system, which allows law-abiding citizens to access medicines containing pseudoephedrine, while stopping sales that exceed the legal limit.

    The passage was lauded by the Consumer Healthcare Products Association.

  • FDA rejects Teva's request to block Watson's generic Seasonique

    PARSIPPANY, N.J. — A federal court has rejected Teva Pharmaceutical Industries’ efforts to prevent Watson from launching a generic version of one of its drugs, Watson said Friday.

    The U.S. District Court for the District of Nevada denied Duramed Pharmaceuticals’ request for an injunction to keep Watson’s generic version of the contraceptive Seasonique (levonorgestrel and ethinyl estradiol 0.15 mg/0.03 mg) and ethinyl estradiol 0.01 mg from being launched.

    Seasonique is made by Teva Women’s Health, the successor of Duramed.

  • FDA approves Nulojix

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for preventing organ rejection in kidney transplant patients, the agency said Wednesday.

    The FDA approved Bristol-Myers Squibb’s Nulojix (belatacept), for preventing acute rejection in adult patients. The drug is approved for use with other immune system-suppressing drugs, specifically Novartis’ Simulect (basiliximab), Genentech’s CellCept (mycophenolate mofetil) and corticosteroids.

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