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Regulatory and Washington

  • Mylan generic drug for HIV/AIDS receives tentative FDA approval through PEPFAR

    PITTSBURGH — Under the President's Emergency Plan for AIDS Relief, the Food and Drug Administration has given tentative approval to a generic HIV and AIDS drug made by Mylan, the company said.

    The drug maker's Mylan Labs subsidiary received tentative approval for atazanavir sulfate and ritonavir tablets in the 300-mg/100-mg strength. The FDA's tentative approval of the drug under PEPFAR means it will be eligible for purchase in certain developing countries.

  • 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.

  • Warner Chilcott sues Mylan, Famy Care over Generess Fe patent challenge

    PITTSBURGH — Generic drug maker Mylan and a partnering company are challenging the patent on a contraceptive drug.

    Mylan said Thursday that it and Famy Care had been sued by Warner Chilcott in the U.S. District Court for the District of New Jersey following their filing of a regulatory approval application with the Food and Drug Administration for norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets, a generic version of Warner Chilcott's Generess Fe.

  • 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.

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