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Regulatory and Washington

  • The Online Pharmacy Safety Act of 2011 introduced in Senate, endorsed by NACDS

    ALEXANDRIA, Va. — A new bipartisan bill introduced in the Senate seeks to protect consumers from Internet drug sellers posing as legitimate pharmacies.

  • FDA approves new labeling for ViroPharma's Vancocin

    EXTON, Pa. — ViroPharma has received approval for updated labeling to its antibiotic drug.

    The drug maker announced that the Food and Drug Administration approved the "modernization" of labeling for Vancocin (vancomycin hydrochloride) capsules. The new label includes clinical safety and efficacy data for the drug in treatment strains of Clostridium difficile bacteria currency circulating.

  • Rule issued by Obama administration seeks to reduce, prevent drug shortages

    WASHINGTON — The Obama administration on Thursday issued an interim final rule that will help prevent prescription drug shortages.

    The rule, the administration said, will require manufacturers (that are the sole producer of certain critical drugs) to report to the Food and Drug Administration all interruptions in manufacturing of products.

  • DXM abuse down among high school seniors; overall Rx and Vicodin abuse up

    WASHINGTON — Approximately 5.3% of high school seniors abused over-the-counter cough-cold medicines in the past month, according to the latest "Monitoring the Future" survey released Wednesday by the National Institute on Drug Abuse. That's down from 6.6% of high school seniors who claimed to have recently abused cough-cold medicines last year.

  • FDA to review patch for HIV-related pain

    SAM MATEO, Calif. — A Food and Drug Administration expert panel will review a drug made by NeurogesX as a potential treatment for pain associated with HIV.

    NeurogesX said Thursday that the FDA Anesthetic and Analgesic Drug Products Advisory Committee would meet on Feb. 9, 2012, to review the patch drug Qutenza (capsaicin) as a treatment for pain associated with HIV-associated peripheral neuropathy, or HIV-PN.

    The drug currently is approved for treating pain associated with postherpetic neuralgia.

  • NACDS, NCPA commend Reps. Rogers, Braley for concern over draft FUL lists

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores and National Community Pharmacists Association issued a statement on Thursday announcing that they commend Reps. Bruce Braley, D-Iowa; Mike Rogers, R-Mich.; and 38 of their colleagues who expressed concerns with draft Federal Upper Limits lists that recently have been published by the Centers for Medicare and Medicaid Services.

  • GPhA proposes new initiative to target drug shortages

    WASHINGTON — The Generic Pharmaceutical Association proposed Thursday the creation of a new initiative to combat the problem of drug shortages.

  • Nearly 60 franchisees file claims against Medicine Shoppe, Medicap

    ST. LOUIS — A group of Medicine Shoppe International and Medicap franchise owners is filing claims against the two companies over an alleged breach of contract and failure to support the franchise systems.

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