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Regulatory and Washington

  • FMI announces executive changes

    ARLINGTON, Va. — The Food Marketing Institute announced that one of its former executives is rejoining the organization, while another will be retiring.

    FMI announced last Friday that Patrick Davis has rejoined the organization as its VP state government relations, where he will serve as the principal liaison between FMI and state associations. Prior to rejoining FMI, Davis served as president and founder of Alliance Consulting.

  • Gerber gets green light from FDA to tout health claim

    FLORHAM PARK, N.J. — A milk formula for babies made by Gerber Products can reduce the risk of atopic dermatitis, and Gerber has the Food and Drug Administration’s permission to say so.

    Gerber said Thursday that its Good Start milk-based formulas were the first and only infant formulas to meet the FDA’s criteria for a qualified health claim. The partially hydrolyzed formula may reduce a baby’s risk of developing atopic dermatitis in the first year.

  • Teva to market generic Combivir tablets

    JERUSALEM — Teva Pharmaceutical Industries is set to market a generic version of an HIV treatment, the drug maker announced Thursday.

    Teva said it will launch generic Combivir tablets (lamivudine and zidovudine) and is eligible for a 180-day period of marketing exclusivity, according to the Food and Drug Administration. The drug maker is expected to ship the drug in fourth quarter 2011, per terms of a settlement agreement between Teva, Glaxo Group and ViiV Healthcare.

  • NCPA busy on Capitol Hill

    ALEXANDRIA, Va. — Capping off a meeting that brought hundreds of independent community pharmacists to Washington for the National Community Pharmacists Association Legislative Conference, members of Congress joined pharmacists at the Capitol on Wednesday to discuss the cost-saving services provided by local pharmacies now and in the future.

  • Globe All Wellness recalls lots of Slim Xtreme product

    HOLLYWOOD, Fla. — Globe All Wellness on Tuesday recalled all lots of its Slim Xtreme herbal slimming capsule upon learning that the Food and Drug Administration determined the product contains the undeclared drug ingredient sibutramine.

    Sibutramine was the active ingredient in the prescription weight-loss drug Meridia, which had been pulled off the U.S. market due to increased risk of cardiovascular events or stroke.

  • FDA issues warnings to online retailers making 'unsubstantiated claims' about tobacco products

    SILVER SPRING, Md. — The Food and Drug Administration sent 11 warning letters last week to online retailers selling tobacco products that claimed to reduce the harm and risk of tobacco-related disease.

    The FDA said Wednesday that the retailers had illegally marketed tobacco products that used such terms as “light,” “low,” “mild,” “less toxic” and “safer” — terms that the agency deems misleading and unsubstantiated.

  • Congressman honored by HDMA

    ARLINGTON, Va. — The Healthcare Distribution Management Association on Wednesday honored Rep. Gene Green, D-Texas, with its Rx Safety and Healthcare Leadership Award.

    The award recognizes public officials for their leadership and commitment to public policies that support and promote the safe and efficient delivery of life-saving medicines to patients nationwide.

  • Mylan launches generic Roxicodone through deal with Coastal Pharmaceuticals

    PITTSBURGH — Mylan has launched a generic version of an opioid painkiller, the company said Wednesday.

    Mylan announced the launch of oxycodone hydrochloride tablets in the 5-mg, 15-mg and 30-mg strengths. Mylan is launching the drug under a development and supply agreement with Coastal Pharmaceuticals.

    The drug is a generic version of Xanodyne’s Roxicodone, a treatment for moderate to severe pain. Oxycodone hydrochloride tablets had sales of about $325 million during the 12-month period ended in March, according to IMS Health.

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