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Regulatory and Washington

  • Ranbaxy resumes production of cholesterol drug ingredients

    NEW YORK — Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.

    The Indian drug maker said it had initiated corrective and preventive actions, or CAPA, as it prepared to resume supplies of generic atorvastatin calcium tablets to the U.S. market. The drug is a generic version of Pfizer's Lipitor, and Ranbaxy became the first company to market a generic version in November 2011.

  • FDA approves Bayer's Stivarga for gastrointestinal stromal tumors

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

    The FDA announced the approval of Stivarga (regorafenib) for gastrointestinal stromal tumors that could not be removed through surgery or had spread to other parts of the body and were no longer responding to treatment with Novartis' Gleevec (imatinib) or Pfizer's Sutent (sunitinib).

  • CDC: Flu incidence drops to 2.8%

    ATLANTA — The proportion of outpatient visits for influenza-like illness was 2.8% for the week ended Feb. 16, the Centers for Disease Control and Prevention reported Friday, a strong indicator that the 2012-2013 flu season is on its way out. Nevada, New Jersey and Vermont were still reporting high ILI activity; while 13 states and New York City reported moderate activity; 11 states reported low activity; and 23 states reported minimal activity.

  • FDA approves Amneal opioid-dependence drug

    BRIDGEWATER, N.J. — Amneal Pharmaceuticals has received approval from the Food and Drug Administration for a drug to treat opioid dependence.

    Amneal announced Monday the approval of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, a generic version of Reckitt Benckiser Healthcare's Suboxone.

    Suboxone had sales of $1.5 billion in 2012, according to IMS Health.

     

  • NACDS hires rock legend Roger Daltrey to perform at TSE

    NEW YORK — "Who are you?" That question probably won't be necessary as the famous frontman of British Invasion band The Who takes the stage at the National Association of Chain Drug Stores' Total Store Expo in August.

    The NACDS said it had hired Roger Daltrey to perform at the show, which takes place in Las Vegas from Aug. 10-13 and combines the group's Pharmacy and Technology, Marketplace and Supply Chain and Logistics shows. Daltrey will perform on Aug. 12.

  • As legislators push for warnings, energy drinks sales soar

    The energy drink category, which has enjoyed double-digit sales and unit growth for several years, faces increasing scrutiny from the Food and Drug Administration.

    The FDA has said it will consider requiring companies to disclose the amount of caffeine in the drinks and add warnings about possible side effects on labeling.

  • APhA survey finds growing demand for MTM services

    WASHINGTON — The American Pharmacists Association has released the latest edition of a publication for pharmacists who provide medication therapy management services, the professional group said Monday.

  • Generic tsunami eases, but leaves transformed Rx landscape in its wake

    The generic drug tidal wave became a tsunami in 2012, with some of the world's top-selling pharmaceuticals swamped by generic competition, and health plan payers scrambling to reap billions of dollars in financial savings.

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