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Regulatory and Washington

  • ABC's 'Nightline' shadows three meth busts

    NEW YORK — ABC's "Nightline: Late Evening News" on Wednesday aired an exposé on Kentucky's methamphetamine problem, shadowing law enforcement as they made three arrests in a state that employs an electronic tracking system for the over-the-counter ingredient pseudoephedrine. The officers investigated sales made at Walgreens, CVS and Walmart.

  • Six retailers charge Wyeth, Teva with unlawfully delaying generic Effexor XR

    TRENTON, N.J. — Six retailers on Wednesday filed suit naming Wyeth and Teva Pharmaceuticals as defendants and alleging that the defendants unlawfully delayed the entry of generic versions of Wyeth's antidepressant Effexor XR (venlafaxine). A summons was issued to Wyeth and Teva on Thursday.

    The retailers include Ahold USA, H-E-B, Kroger, Safeway, Supervalu and Walgreens. The companies are suing for three-times damages plus attorneys fees.

    Wyeth was acquired by Pfizer in October 2009.

  • U.S. marshals seize supplements marketed as drugs

    HILLSBORO, Wis. — At the request of the Food and Drug Administration, U.S. marshals on Thursday seized all dietary supplements manufactured by Syntec because of false claims made about the safety and effectiveness of their supplements in treating a number of diseases.

  • Octapharma USA reintroduces Octagam 5%

    HOBOKEN, N.J. — A drug for treating immune system disorders is available again following a voluntary market withdrawal last summer.

    Octapharma USA said Wednesday that Octagam (immune globulin intravenous [human] 5% liquid preparation) again was available for purchase. The Food and Drug Administration approved its reintroduction on Nov. 3.

  • Supervalu, Walgreens sign on to Obama's Better Buildings Challenge

    WASHINGTON — President Barack Obama on Friday announced nearly $4 billion in combined federal and private-sector energy upgrades to buildings over the next two years. These investments will save billions in energy costs, promote energy independence, and, according to independent estimates, create tens of thousands of jobs in the hard-hit construction sector.

  • CHPA, CRN call on FDA to drop NDI guidance

    WASHINGTON — The Consumer Healthcare Products Association and the Council for Responsible Nutrition on Friday jointly filed comments with the Food and Drug Administration seeking withdrawal of its New Dietary Ingredient Draft Guidance, and calling upon the agency to work with stakeholders on a revised version that will maintain the current scope and intent of the Dietary Supplement Health and Education Act of 1994.

  • Ranbaxy launches generic Lipitor

    SILVER SPRING, Md. — Ranbaxy Labs got the green light from the Food and Drug Administration Wednesday night to launch its generic version of Pfizer's cholesterol-lowering drug Lipitor.

    The FDA announced the approval of Ranbaxy's atorvastatin calcium tablets in the 10-mg, 20-mg, 40-mg and 80-mg strengths. New Brunswick, N.J.-based Ohm Labs will manufacture the drug.

  • FDA issues draft guidance to investigators, manufacturers of artificial pancreas systems

    SILVER SPRING, Md. — In an effort to help advance the development of devices that automatically monitor blood glucose and provide proper insulin doses in people with Type 1 diabetes, the Food and Drug Administration has issued draft guidance to help investigators and manufacturers as they develop and seek approval for these products.

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