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Regulatory and Washington

  • Impax faces generic Oxycontin patent challenge

    HAYWARD, Calif. — Another generic drug maker is seeking to market its version of a popular opioid painkiller.

    Impax said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s Oxycontin (oxycodone) controlled-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.

    Purdue filed suit against Impax on April 8 in the U.S. District Courts for the Southern District of New York, seeking to prevent Impax from marketing its version before the expiration of Purdue's patents.

  • Sandoz gets FDA nod for Altavera

    PRINCETON, N.J. — The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

    Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Altavera (levonorgestrel and ethinyl estradiol) tablets, a generic version of Duramed’s Nordette.

    Branded and generic versions of Nordette had sales of about $57.4 million during the 12-month period ended in February, according to IMS Health.

  • P&G recalls 10 shades of Clairol Natural Instincts

    CINCINNATI — Procter & Gamble has announced a voluntary recall of 10 shades of its Clairol Natural Instincts in the United States, Canada and Puerto Rico because of a mismatched ColorFresh! Revitalizer sachet in the kits that may create an unwanted color result.

  • Hi-Tech granted tentative approval for generic Levaquin

    AMITYVILLE, N.Y. — The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.

    Hi-Tech announced the tentative approval of levofloxacin oral solution in the 25 mg-per-mL strength. The drug is used to treat mild, moderate and severe bacterial infections in adults.

  • NCPA: Florida’s Medicaid Managed Care pilot program raises concerns

    ALEXANDRIA, Va. — A Georgetown University Health Policy Institute study of Florida’s Medicaid Managed Care pilot program should raise doubts for states considering the use of for-profit managed care companies to reduce Medicaid costs, the National Community Pharmacists Association cautioned on Friday.

  • Watson faces patent challenge over generic Vigamox

    PARSIPPANY, N.J. — Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

    Watson Labs filed an abbreviated new drug application with the Food and Drug Administration for moxifloxacin hydrochloride ophthalmic solution USP in the 0.5% strength. The antibiotic solution is a generic version of Alcon's Vigamox, which had total U.S. sales of about $281 million ended in February, according to IMS Health.

  • HHS seeks to reduce health disparities

    WASHINGTON — The Department of Health and Human Services on Friday launched two plans aimed at reducing health disparities.

    “For the first time, the United States has a coordinated road map designed to give everyone the chance to live a healthy life,” stated HHS secretary Kathleen Sebelius. “We all need to work together to combat this persistent problem so that we can build healthier communities and a stronger nation.”

  • NCPA to Texas government: Contain Medicaid costs by utilizing community pharmacists

    ALEXANDRIA, Va. — Texas policymakers seeking to contain Medicaid costs should utilize community pharmacists to achieve both savings and optimal health outcomes, the National Community Pharmacists Association suggested on Thursday.

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