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Regulatory and Washington

  • Impax challenges Abbott's Simcor patent

    HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.

    Impax said it had filed an approval application with the Food and Drug Administration for niacin and simvastatin extended-release tablets in the 1,000 mg/20 mg strength. The drug is a generic version of Abbott Labs’ Simcor.

  • FDA tentatively approves Sun's generic Cymbalta

    MUMBAI, India — A generic drug maker announced that the Food and Drug Administration has granted tentative approval for its version of a popular antidepressant.

    Sun Pharmaceutical Industries said the FDA approved its duloxetine hydrochloride delayed-release capsules in 20-mg, 30-mg and 60-mg strengths. The capsules are a generic version of Eli Lilly's Cymbalta, which is indicated to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain.

  • J&J recalls lots of Tylenol product over labeling

    BOSTON — Johnson & Johnson recalled lots of its Tylenol Cold Multi-Symptom liquid products due to insufficient labeling, the company said Wednesday.

    The products are not being recalled due to reports of any adverse events associated with taking the product, the company added.

    Earlier this week, the company recalled additional lots of millions of packages of Children's Benadryl and children's Motrin.

  • FDA approves Axiron

    INDIANAPOLIS — Eli Lilly and Australian drug maker Acrux have received approval from the Food and Drug Administration for a testosterone replacement therapy for men, the two companies announced Tuesday.

    The FDA approved Axiron (testosterone) topical solution as a treatment for men with various conditions that lead to deficiency of the hormone. The drug, a controlled substance, is designed for application under the arm.

  • Seizing on new study of Part D plans, NCPA urges seniors to choose carefully

    ALEXANDRIA, Va. — More than ever, seniors who rely on Medicare need to carefully evaluate the dizzying array of prescription drug plan choices available to them, as the 2011 enrollment period for Medicare Part D drug benefit program goes into high gear, independent pharmacy leaders declared Tuesday.

  • NACDS promotes pharmacy’s contribution as NCQA mulls health quality standards

    ALEXANDRIA, Va. In another bid to boost the standing of pharmacists in a changing healthcare system, the National Association of Chain Drug Stores urged a leading healthcare think-tank and advocacy group to adopt health quality standards that include a broader role for retail pharmacy professionals.

  • Industry organizations join forces to dispute new FDA restrictions

    COLORADO SPRINGS, Colo. Several organizations representing retailers and consumer healthcare product manufacturers want Congress to reverse a provision in the healthcare-reform act that would prohibit the use of flexible spending accounts to purchase over-the-counter medicines without a prescription.

  • Report: PhRMA's lobbying efforts total more than $5 million in Q3

    NEW YORK The pharmaceutical lobby spent more than $5 million lobbying the government during the third quarter, according to published reports.

    Based on a filing with the government, BusinessWeek reported that the Pharmaceutical Research and Manufacturers of America spent $5.2 million lobbying on issues ranging from healthcare legislation to drug importation and marketing.

    This compared with $6.8 million in third quarter 2009, according to the magazine.

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